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الصفحة الرئيسية
عن الهيئة
نظرة عامة
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كلمة رئيس المجلس الأعلى للصحة
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الهيكل التنظيمي للهيئة
الخطة الإستراتيجية للهيئة 2021-2025
التقرير السنوي
آليات تنفيذ الحوكمة
ميثاق خدمة العملاء
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قسم تنظيم المهن الصحية
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مجموعة الاعتماد والجودة
قسم تنظيم المؤسسات الصحية
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مجموعة الشئون القانونية
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قسم الشكاوى والتحقيقات الطبية
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قائمة الإجراءات التصحيحية للسلامة الميدانية
إشعار السلامة الميدانية
قائمة الإجراءات التصحيحية للسلامة الميدانية
اشعارات السلامة الميدانية
قائمة الإجراءات التصحيحية للسلامة الميدانية
قائمة الأجهزة المسحوبة
Roche Diabetes Care:
AccuCheck Insight Insulin pumps
Medtronic:
Cyber Security
Minimed Insulin pump
Minimed 600 series insulin pumps
Abbott:
FreeStyle Libre flash glucose sensor
Hamilton Medical AG:
Hamilton G5-Ventilator
Beckman Coulter:
DxH 800
Remisol Advance
Seca Ltd:
Baby Scale Carts
Maquet Datascope:
CardioSave Hybrid IABP & CardiSave Rescue IABP
Baxter Healthcare:
Prismaflex Control Unit
Prismaflex Control Unit
Imtmedical AG:
Ventilators
Phillips Healthcare:
HeartStart XL Defibrillator Monitor
Stryker:
Lifepak 15 monitor-defibrillator
Getinge Maquet:
Intra-aortic Baloon Pumps
Siemens Healthcare Diagnostics Inc:
ADVIA Chemistry systems-Enzymatic Creatinin
GE Healthcare:
Fluoroscopy system Connexity
Anesthesia Devices
Carestation 600 Series Anesthesia System
s
Dragerwerk AG & Co. KGaA:
Oxylog VE300 ventilator
RaySearch Laboratories:
Ray station
Draeger:
Ventilators
BD Diagnostic Systems:
Infusion Pump Systems
QIAGEN GmbH:
Rotor-Gene Q Software update
Philips Therapeutic Care:
Philips V60 Ventilators
Rayen Healthcare Products Limited:
Dana Vinyl Powdered Gloves - Rayen Healthcare Products Limited / Deeko Bahrain - risks associated with use of powdered gloves
Multiple Manufacturers:
Surgical Staplers and Staples
Cybersecurity Vulnerabilities in a third-Party Software Component(IPnet)
SweynTooth Family
Medical Devices containing Mercury
Disinfectant Chamber
MDR_Circular_31_2020_Using infrared thermometer
OneTouch Select Plus- LifeScan, Europe, GmbH - manufacturer error in some test strips.
CFx Longevity Estimator Software Error - Medtronic - availability of software updates to correct inaccurate longevity estimate for a well-defind subset.
Lutonix Drug Coated Balloon Catheter - BARD GmBh - increased risk of late death
GreenLight MoXyTM Laser Fiber - Boston Scientific - New IFU to
reduce the likelihood of metal cap and fiber tip break temperature.
Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation and Giraffe OmniBed Carestation
Central Monitoring Systems,
Patient Monitors - Philips - Cybersecurity vulnerabilities.
Breast Tissue Expanders (CPX4) -
Mentor - awareness of the presence of a magnet in the dome of MENTOR
®
Breast Tissue Expanders (CPX4).
Neonatal and pediatric ventilator - Acutronic Medical Systems AG - a malfunction associated with over-delivery of peak-inspiratory pressure with delayed or absent alarm.
Sika hand sanitizer- Sika Gulf- amount of sterile alcohol is less that 70%.
Patient Cables/lead sets -
Welch Allyn -
product may not meet the performance
Face Masks - All manufacturers- metal piece burns patient during an MRI
BD Max SARS-CoV-2 Reagent - BD -
potential for false positive.
Cobas 6500 Urine Analyzer - Roche Diagnostics - possible mismatch in results of same sample
Benchmark Ultra Stainer Module - Roche Diagnostics - fluid leaks that created an electrical short inside the power socket
Artiset HD DNL HC, Artiset Prepost, Artiset HD SN HC - Baxter Healthcare Corporation - a kinked access line has the potential to cause delay in therapy
Apex Hole Eliminator (HE) used with Pinnacle cup devices -
J&J Depuy Synthes - potential of an out of specification condition.
SynchroMed II Implantable Drug Infusion Pump - Medtronic - pump programming sessions are not fully completed resulting in patient's therapy stop.
Strata II, Delta, and CSF-Flow Control Valves and Shunts - Medtronic - potential for variation in radiopaque marking visibility under radiographic imaging.
Implantable Cardioverter Defibrillators (Amplia MRI) - Medtronic - some of ICDs may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation.
Interstim system advanced lead Quad SNS tined CAN OUS L 163 - Medtronic - extension connector has migrated from the future stimulator pocket site along the tunneling pathway.
PrismaFlex Control Unit - Baxter Healthcare Corporation - variability in the performance of the tubing in the ARPS Pump Assembly.
Aeonmed, VG70, Critical Care Ventilator - Beijing Aeonmed Co., Ltd - Software version, which did not have a build-in atmospheric pressure sensor, were placed on the market with an incorrect instruction for use.
Paclitaxel-coated devices - Safety Alert.
Alaris GP, Alaris GP Guardrails, Alaris neXus GP - Becton Dickinson (BD) - potential to exhibit spurious counting of Flow Sensor pulses. This is resulting in the reporting of false flow error.
Minisart Filter 16534-K 5μm Sterile filter
-
Gilead- quality defect issue, filter piece may release fibres and particles.
Irrigated Catheters - Biosense Webster, Inc - reinforce the importance of verifying all device settings prior to ablation with an irrigated catheter.
C Reactive Protein Gen 3 - Roche - higher test imprecision at lower concentration on all cobas c systems.
Intrauterine Device - EUROGINE, S.L - an increase in horizontal arm breaks at the time of extraction of the Ancora IUD model.
Kangaroo Enteral Feeding Pump Sets - Covidien, Cardinal Health LLC - potential for air appearing in the enteral feed pump set tubing during set-up.
disinfection gate - spraying of individuals with disinfectants could be harmful and the toxic and can lead to eye and skin irritation.
Access SARS-CoV-2 IgG II assay - Beckman Coulter - difference between the Access 2 / UniCel DxI Instrument Instructions for Use (IFU) and the result descriptions.
AU Bicarbonate Calibrator - Beckman Coulter - incorrect expiry date on the package.
Subset of ASSURITY™ AND ENDURITY™ PACEMAKERS - St. Jude Medical Inc - Malfunction caused by intermittent incomplete mixing of epoxy during manufacture.
Blood purification device - Infomed SA - Number of bugs and technical issues corrected through software updates.
cardiac implantable devices -an interference between iphone 12 and cardiac implantable devices caused by the strong magnetic field from the cell phone.
HVADTM Power Cables, Monitor Data Cables, and Controller Ports -
Medtronic - potential for the Controller power cables to cause damage to the HVADTM Controller ports.
HVAD Pump Implant Kit - Medtronic - the device may fail to initially start, restart, or have a delay in restarting after the pump was stopped.
HeartwareTM HVADTM System Instructions for Use and Patient Manual Updates -
Medtronic - upcoming updates to the HVAD™ System Instructions for Use (IFU) and Patient Manual (PM).
Magnus 1180 Operating Table Column - Getinge Maquet - a problem may cause the operating table not to function as intended.
Lifpak CR2 Defibrillators - Stryker - lid magnet has dislodged from the device, which may result in premature battery depletion.
Intellis™ Model 97755 Recharger - Medtronic - unintended increased heating, specifically due to damage at the location where the cable enters the recharger antenna.
Treatment chair 500 ECO - UFSK-International OSYS GmbH - head-side lowering of the lying surface possible due to inadequate seat and backrest drive.
Launch information of Elecsys immunoassay versions with increased biotin tolerance (Wave 2) - Roche Diagnostics.
Dialysis Devices - Delta Med SPA - Possible Deviations of Sterilization Process Parameters.
(List)
Annex 1-List of Medical devices under recall procedure
Program Chip Urisys 1100 - Roche Diagnostics - glitch in the program causing erroneous results.
JELONET - smith + Nephew - the pouch with an open seal is not detected
- (Report)
S+N report
Datex
-
Ohmeda Anesthesia Machines -
GE Healthcare -
damaged tubes
with small punctures or
cuts.
GYNECARE INTERCEED - Ethicon -
clinical study was recently conducted to evaluate the effect
of
INTERCEED™ in preventing abdominal adhesions in patients with colorectal carcinoma.
HVAD Pump Implant Kit - Medtronic - Difficulty in pulling back the driveline cover over a strain relief repair.
Accu
-
check Aviva / Accu
-
check Performa test strips - Roche Diabetes -
vial can open in a sealed carton while in transit.
Accu Chek
Inform II Test Strips -
Roche Diagnosis -
positively biased results due to vials being open within the sealed carton prior to
use.
Atrium Ocean
Water Seal Chest Drain Product -
Atrium/Getinge -
possibility of pneumothorax because of improper set up of Atrium Ocean
Water Seal Chest Drain.
BD
SmartSite™ Needle Free Valve - BD -
potential issues with the
valve of the Needle
-
free Connector.
Cardiosave Li
-
Ion Battery Packs -
Getinge -
potential risk of unexpected
short battery runtime.
Cobas u pack
(400 strips) -
Roche Diagnostics - The newly collected data deviated in some case.
Datascope Cardiosave Hybrid and Cardiosave RescueInta-Aortic Balloon Pump - Getinge - possibility of fluid ingress.
ORTHO VISION and ORTHO VISION Max BioVue Analyzers -
ORTHO VISION -
the potential for intermittent false positive results.
PediaSat Catheter -
Edwards Lifesciences SA -
leaks during use.
Perc
i
Control
Anti HBs - Roche Diagnostics -
N
ew
reagent lot specific control tar
get values
and ranges have been assigned for Perc
i
Control
Anti HBs.
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30, and BiPAP A30/A40 Series Device Models
-
Philips
Res
pironics -
foam may degrade into particles which may enter the device’s air
pathway and be ingested or inhaled by the user.
ENFit Low Dose
Tip Syringe -
potential for overdose if the user does not clear the moat area around
the tip of the ENFit LDT syringe before administering a
medication.
FreeGo
Enteral
Feeding
Pump -
Zevex
Inc
repeated
user
error
of
not
clearing
alarms
per
the
instructions
for
use.
MR Systems - GE -
the “Patient Orientation” button can inadvertently be clicked when intending to click on the “Save RX” button
Strata II, Delta, and CSF-Flow Control Valves and Shunts - Medtronic-
potential for variation in radiopaque marking visibility.
Irrigated Catheters - J&J -
importance of verifying all device settings prior to ablation with an irrigated catheter.
LullabyTM Resus Plus/Prime -
GE Healthcare -
defect in the dovetail mount accessory.
Azure, Astra IPGs, Percepta, Serena, Solara CRT-Ps - Medtronic -
availability of software updates to address a potential inaccurate longevity estimate that may occur with the pacemakers.
Synergy Cranial S7 and Stealth Station Crania -
Medtronic Navigation, Inc -
potential inaccuracy during biopsy procedures
using the ™ S7 and i7
Biopsy Depth Gauge feature.
ECG Suction Electrodes - Serious side effects associated with the use of this type of electrodes.
Abre
venous self
-
expanding stent system - Medtronic - updates in IFU to avoid risks of stent migration.
Benchmark Ultra
Stainer Module - Roche Diagnostics - fluid leak that could lead to electrical shortcut in the instrument.
BILT
3, LAC
2 , IgM
-
2 -
Roche Diagno
s
tics -
interferences
in serum/plasma, urine
and
CSF
where
assessed for the
i
r
potential
risk
on all
Roche tests
and pl
atforms
.
Reveal L
I
NQ - Medtronic -
partial electrical reset resulting in the inability to detect Brady and Pause
events.
MAFEC Device System -
NuVasive Specialized Orthopedics, Inc - updates in the IFU.
Elecsys
Troponin - Roche Diagnostics -
The recovery of Elecsys Troponin I samples can be decreased.
Elecsys
DHEA
–
S CalSet - Roche Diagnostics - this
model number
can not be used on cobas e 411 and
cobas e 601 instruments due to a numbering error.
PerciControl ClinChem Multi 2 and 1 - Roche Diagnostics -
erroneous for BILT3 values and ranges in the e
-
barcode and eValue sheet for cobas c
303.
Precinorm PUC - Roche Diagnostics -
the recovery of urine control Precinorm PUC for the Tina
-
Quant albumin Gen.2
urine application showed an out of specification event on cobas c 503 during a QC release event.
Cobas u 701
microscopy analyzer / Cobas u 601 urine analyzer - Roche Diagnostics -
availability of addendums to the operator’s manuals.
MINICAP EXTEND
LIFE PD TRANSFER SET - Baxter - Damage or leak due to the use of cleaning products.
Atrium Advanta V12 Covered Stent System - Getinge
-
sep
arating of the balloon or catheter hub from
the delivery catheter over a
3
-
year period.
cleaning instructions.
CARESCAPE Central Station (CSCS) V2.0 - GE Healthcare - cannot be used with un-approved keyboard that contains a mute key.
(HVAD) cleaning of controller connector - Medtronic - updating of cleaning instructions.
Veritor Plus Analyzer - Becton Dickinson -
potential to overheat and/or cause fire when used unauthorized AC power adapter.
VITROS®
Immunodiagnostic Products HIV Combo Reagent -
Ortho Clinical Diagnostics - false repeat Reactive results when using certain lots.
FORE-SIGHT ELITE Tissue Oximeter Module -
Edwards Lifesciences -
The StO
2
values may be inaccurately low when using with
the Fore
-
Sight Elite large sensor (FSESL) in certain somatic locations (arms and legs).
BD Alaris™ System PC Unit 8015 - Becton Dickinson -
s
ome customers use third party replacement parts that may affect the safety of the device.
Enteral Feeding Delivery Sets -
risk of strangulation from the use of enteral feeding delivery sets.
Disposal Grasping Forceps - Olympus -
Forceps can be difficult to open and
close and
do not comply
with Olympus standards for force required to open and close the forceps.
Vinci X/Xi Vessel Sealer Extend -
Intuitive Surgical Inc - bleeding due to placing excessive tissue in the instrument jaws of the vessel sealer extend.
Fast Flow Fluid warmer ,I.V Fluid Administration set -
Smiths Medical International Ltd - potential for aluminium ion leaching into warmed fluids
Ventilator - Philips -
potential issue
s
that could affect the main electrical circuit.
Surgical Staplers -
SFDA Recommendation
for Healthcare
Providers Regarding Surgical Staplers.
BD Plastipak™ 50mL syringe -
Becton Dickinson - an
observation of air in a damaged syringe while being used in a pump.
Atlan devices with SW1.01 Build 63421 -
Drägerwerk AG & Co. KGaA
-
oscillations may occur on the displayed pressure and flow
curve during inspiration in
pressure
-
controlled v
entilation modes (PCV, PSV and VC
-
AF)
MUSE™ NX R1 systems with Web Edit option - GE Healthcare
-
Edits to measurements and diagnosis statements can be lost after a test is
Signed
in
the MUSE NX web client.
Puritan Bennett™ 980 Series Ventilator - Medtronic - audible alarm failure, the omni-directional LED visual alarm may not illuminate as described in the Operator Manual.
Various Systems Using Apache Java Log4j Library Utility - Multiple Manufacturers - critical Remote Code Execution vulnerability.
Boge
compressor - Drägerwerk AG & Co. KGaA -
the manufacturer
realized that the
compressor may start unintendedly during maintenance.
Radiological computer-aided triage - recommended instructions to ensure the correct use of the device by the healthcare providers.
Atomlab™ 500 Dose Calibrator -
Biodex Medical Systems - software error
When de
leting a previously entered custom isotope.
HeartWare™ Ventricular Assist Device(HVAD™) System - Medronic -
suspicion of pump thrombosis.
Calcium Gen.2 - Roche Diagnostics - change in the parameters for the
Calcium Gen.2
Elecsys
Folate III - Roche Diagnostics -
signal loss issue has been confirmed with the
mentioned
reagent kit lots
.
MSS CASSETTE GLU/LAC/UREA - Roche Diagnostics - lot number did not show any results for the Urea parameter and was mistakenly released as a MSS Glucose / Lactate / Urea Cassette.
Absolute Pro LL Peripheral Self‐Expanding Stent System - Abbott -
mechanical locking, stent deployment and partial stent deployment
failures, resulting from unintended excessive force u
sed to deploy the stent.
ATTUNETM MEASURED SIZING & ROTATION GUIDE INSTRUMENT
Oxylog 3000 FAMILY
DEFIGARD Touch7
BD Veritor™ Plus Analyzer
PAS Staining Kit for BenchMark Special Stains Instruments
ICD CROME VR MRI DF4&ICD CROME DR MRI IS1 DF4 – Medtronic - potential for Intermittent-Reduced-Energy Shock
ICD CROME VR MRI DF4&ICD CROME DR MRI IS1 DF4 F
S
N – Medtronic - Setting VF ATP During Charging Therapy
Minimed TM 600 and 700 series insulin Pump – Medtronic - issue relating to the battery cap on the pumps
EVERFLEX ENTRUST - Medtronic - updates in IFU.
VIDAS® 3 Software version 1.4.0 or v1.4.1. - Biomerieux - unexpected error after performing calibration.
PreWash failure after Preparation in Quick Start mode on cobas® e 801 and e 402 - Roche Diagnostics.
Centricity Universal Viewer and Universal Viewer -
GE Health care -
inaccurate measurement values can be displayed.
HeartWare™ Ventricular Assist Device(HVAD™) System - Medtronic -
improving battery performance and address quality issues.
ORTHO CONNECT Enterprise Single Instrument BioVue -
Ortho Diagnostic Clinics - error in saving data changings requires software update.
STERRAD® 100NX Sterilization System -
Advanced sterilization Products - Exceeding radiation emissions limits.
SMR5 Software Update for Model 3300 and 3200 Programmers -
BOSTON SCIENTIFIC -
software upgrade to
enable new features on the Model 3300 and 3200 Programmers.
ED-Flow AER / ED-Flow SD AER - Getinge -
incoming water valve can be stuck in open position, causing the machine to
flood the floor.
Haemodialysis and haemofiltration machines - All Manufacturers -
the machine
may not re
-
alarm to alert the user to an ongoing problem.
9100C NXT -
GE HEALTHCARE -
resistors could potentially fail due to electrolytic corrosion.
ORISE™ Gel Submucosal Lifting Agent -
Boston Scientific -
foreign body reaction which presented as mass formations from remnant ORISE Gel post-procedure, prompting unnecessary surgical intervention.
Catheter Fogarty arterial embolectomy catheter -
Edwards Lifesciences LLC -
Some catheters are exhibiting latex deterioration in the balloon.
Cobas e 402 analytical unit, Cobas E 411 analyzer, Cobas e 601, Cobas e 602 and Cobas e 801 module – Roche - an instability issue with specific calibrator lots of Level 2 was observed.
Tina-quant Ferritin Gen.4 for cobas C - Roche Diagnostics - Sensitivity Limit values had not yet been adjusted after value re-assignment due to human error.
CM320-WASHER DRYER WWD LEFT
-
Getinge - corrective action that will be performed to verify and document installation activities for previously installed Getinge CM320-series Washer Disinfectors.
Volista StandOp cupolas -
Getinge -
potential for paint chipping
to occur on the component
located on the fork of the Volista StandOp Cupolas.
ED-FLOW AER, ED-FLOW SD AER - Getinge -
sensor in the ED-FLOW AER chamber may not work as intended and may provide incorrect temperature readings.
All Reusable Duodenoscopes - All Manufacturers -
Detection of contamination after performing sterilization for duodenoscopes.
Alaris Pump Module - Beckton Dickinson - reiterate the importance of using only approved parts with BD Alaris™ System Devices.
B125M ATO MODEL -
GE HEALTHCARE - the
measurement can be inaccurate when used in a location that is not at or near sea level.
CADD SOLIS INFUSION SET -
SMITHS -ICU MEDICAL -
Lack of Delivery or Under delivery related to Tubing Occlusion and false alarms.
Mask with magnet FSN Philips – US - if the mask magnets are placed less than 6 inches away from a metallic implant or device the magnets may cause the device to not perform as intended.
3-0T MR750W GEM ENABLED / 1-ST MR450W 16 CH WITH IROC / 1-ST MR360 WITH DETACHABLE TAB - GE Healthcare - Failure to have proper venting could present a safety issue if the cryogen gas is vented into the MR room during a magnet quench.
Invisalign system -
Align Technology Inc. -
A technical issue related to
the Invisalign system was identified that was affected by the new Treatment Planning History feature within the software.
GE Nuclear Medicine 870 series systems – GE healthcare GMBH - the mitigation may not be correctly implemented ,detector can fall leading tolife-threatening bodily injury.
PENTARAY® NAV Catheters, PENTARAY® NAV eco Catheters -
BIOSENSE WEBSTER INC, US -
the catheters becoming entrapped in the cardiac valvular apparatus and requiring surgical intervention.
FRED easyport plus - Schiller - the
results in the RTU state being incorrectly set to OK if the device crashes during the self-test or shuts off.
MEDUMAT Standard²- WEINMANN MEDICAL TECHNOLOGY - rare cases where the device start as part of the device self-test may lead to a device malfunction.
VITROS Immunodiagnostic Products Intact PTH Reagent Pack -
Ortho Diagnostic clinics -
complaints for VITROS iPTH Reagent Pack related to observations of lower-than-expected iPTH patient and Quality Control (QC) results with the affected lot numbers.
Primus - Drager -
copying, "IP20" was printed onto the type plate in contradiction to the information in the instructions for use.
Revolution Evo -
GE healthcare -
software update and provides the SSA4.1 integration, including updated SSA (Secure Service Access) function as Service Tool.
Datascope Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP) -
Getinge -
possibility of fluid ingress. Fluid entering the Cardiosave IABP may short various electronic components thus leading to system shutdown.
Prefilled Glass Syringes and Certain Luer-Activated Valve (LAV) Connectors - All Manufacturers -
T
he internal pin of the LAV connector may break when attached to a prefilled glass
syringe, causing clog and prevent administration of the drug.
Wash Buffer II -
BECKMAN COULTER, INC -
Wash Buffer II bottles
may leak from the bottle thread after attaching
the nozzle to the bottle
and then inserting the bottle in the wash buffer
reservoir.
FABIE – MEDIPREMA - Fall of a newborn resulting from the manipulation of the FABIE infant radiant warmer by a not intended user.
Elecsys Troponin T hs STAT & Elecsys Troponin T hs - Roche Diagnostics - elevated assay results were observed for K2 EDTA plasma samples.
cobas e 801
&
cobas pure e 402 analytical unit
- Roche Diagnostics - PreWash failure after Preparation in Quick Start mode.
HDL Cholesterol Gen. 4 (HDLC4) & LDL- Cholesterol Gen. 3 (LDLC3)
- Roche Diagnostics - it was found out that the tests show a different sample to reagent pipetting ratio compared to all other members of the cobas c family.
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