GOV.UK
184 alerts for Medical device alert
-
JM103 and JM105 Jaundice Meters – risk of misinterpretation of measurement in hyperbilirubinemia cases.
Draeger Medical Systems – misinterpretation of display may cause delay of treatment of neonatal jaundice.
-
Various Arrow Critical Care devices – recall due to incomplete packaging seals
Manufactured by Teleflex – various critical care devices manufactured from January to December 2017 inclusive have been placed on the market with incomplete packaging seals potentially leading to infection.
-
Cook Vacuum Pump for IVF – risk of electric shock or burn to operator
Manufactured by Cook Medical – risk of electric shock or burn, and failure of the device to operate during IVF procedures because of non-compliant mains wiring.
-
Home use and Point of Care blood glucose monitoring system: Accu-Chek Aviva, Accu-Chek Performa and Accu-Chek Inform II test strips – risk of strip error messages and false high and low blood glucose results
Affected test strips, manufactured by Roche Diabetes Care, may give increased strip error messages prior to dosing with blood and in some cases may give false high or low readings, which may be hard to detect.
-
Gambro Ultrafilter U9000 microbial water filter – updated instructions due to leaks during use resulting in risk of hypovolemia.
Manufactured by Baxter Healthcare – undetected leaks may occur during use after repeated disinfection cycles causing hypovolemia
-
Infinity Acute Care System and M540 Patient Monitors software versions VG2.2-VG6.0 – risk that alarms are not activated
Manufactured by Draeger – a software issue may prevent the activation of audible and visual invasive blood pressure measurement alarms, risking a delay to treatment
-
cobas b 221 instruments with AutoQC module – software limitation affecting automatic QC measurements
Manufactured by Roche Diagnostics GmbH – Under specific circumstances scheduled automatic QC measurements may no longer be performed and erroneous patient results may remain undetected.
-
BD Vacutainer® EDTA & BD Vacutainer® Lithium Heparin Tubes – risk of incorrect results for lead testing or other assays using ASV methodology
Manufactured by Becton Dickinson (BD) – Due to a material in the rubber stopper, affected blood collection tubes may not be compatible with assays using Anodic Stripping Voltammetry (ASV) methodology.
-
Bone Cement: Optipac 40 Refobacin Revision and Optipac 80 Refobacin Revision – Risk of revision
Manufactured by Biomet – risk of revision surgery from an increase in bone cement polymerisation time and reduced mechanical strength.
-
All T34 ambulatory syringe pumps – risk of unintended pump shutdown and delay to treatment
Manufactured by Caesarea Medical Electronics (CME) Ltd – a variation in battery size can cause problems with connections in the battery housing. (MDA/2018/010)
-
Medical device alerts archived in March 2018
Following our latest review of medical device alerts, we have archived the ones listed below.
-
Bag valve mask (BVM) manual resuscitation system – risk of damage to lungs by delivery of excessive pressure
Manufactured by Intersurgical – Valves may be incorrectly oriented, resulting in overpressure of the bag (MDA/2018/009)
-
Aquilon series of nebulisers – CE mark withdrawn and supply ceased
Manufactured by AFP Medical – do not use affected nebulisers as they have been manufactured to unknown standards and their safety cannot be verified (MDA/2018/008).
-
Zimmer Biomet, specific hip and trauma instruments: risk of infection
Manufactured by Zimmer GmbH – recall due to risk of infection as affected instruments may not be adequately cleaned when using standard cleaning instructions (MDA/2018/007).
-
Plum 360 infusion pumps – user actions required to prevent risk of interrupted infusion or delay to treatment
Manufactured by ICU Medical (formerly Hospira) – potential for connectivity engine module to disengage from main chassis, which may lead to power down without an alarm (MDA/2018/006).
-
Roche Tissue Diagnostics (Ventana Medical Systems) – OptiView DAB IHC Detection Kit, UltraView Universal DAB Detection Kit, OptiView Amplification Kit and Hematoxylin II – Dispenser failure of Hematoxylin II and Horseradish Peroxidase reagents
Roche Tissue Diagnostics (Ventana Medical Systems) – Leaking and sticking reagent dispensers may cause weak staining on tissue samples, which may lead to false negatives and misdiagnosis.
-
Recall of specific lots of RUSCH sensor (series 400) silicone and non-sterile rectal/ pharyngeal temperature sensors
Manufactured by Teleflex – risk of misdiagnosis and delivery of inappropriate treatment as sensors may give an inaccurate temperature reading.
-
In vitro fertilisation (IVF) and assisted reproduction technologies (ART) products – precautionary measure
Manufactured by CooperSurgical: specific batches of products were manufactured with increased histamine levels in the gentamicin sulphate.
-
All Philips HeartStart MRx monitors/defibrillators – significant delay in the supply of batteries
The supply of batteries for these devices has been temporarily stopped so there may be a significant delay in the fulfillment of orders for new batteries.
-
Pacemakers and CRT-P - oversensing of minute ventilation sensor signal leading to risk of syncope and pre-syncope
Manufactured by Boston Scientific: specific models only – risk of syncope or pre-syncope due to periods of pacing inhibition from oversensing of the minute ventilation sensor signal (MDA/2018/001)
-
AlterG Anti-Gravity treadmill, model M320, used for rehabilitation after surgery – unexpected surge to maximum speed and failure of the emergency stop
Risk of injury to the patient if the treadmill suddenly goes to top speed.
-
Syringe pumps – required user actions in the event of PL3 alarm to prevent risk of interrupted infusion
BD Alaris/Asena syringe pumps (specific product codes) – internal malfunction may cause PL3 alarm to sound and the infusion to stop (MDA/2017/036).
-
Nasogastric (NG) feeding tubes – recall due to risk of neonatal or paediatric patient choking on ENFIT connector cap
Manufactured by Maxter Catheters – patients could accidentally pull off the connector cap and choke on it. (MDA/2017/035)
-
ThermoScientificTM OxoidTM CAZ10 ceftazidime, CT1629B antimicrobial susceptibility test disc – potential for false resistance results if stored at the wrong temperature
Manufactured by Oxoid Ltd (ThermoFisher Scientific) – antibiotic (ceftazidime) concentration may decrease over time if test disc is stored between 2°C and 8°C: only specific lots are affected (MDA/2017/034)
-
Professional use HIV test: Alere HIV Combo – risk of false positive results
Manufactured by Alere – point-of-care tests for use ONLY in professional clinical settings: specific lots are affected.
-
Intra-aortic balloon pump (IABP): Maquet/Datascope CS100, CS100i and CS300 – potential for interruption or delay to therapy of critically ill patients
Manufactured by Maquet/Gettinge – a false blood detection alarm and/or fluid ingress could result in the failure of therapy to patients
-
IntelliVue patient monitors used with 12-lead ECG – risk of ECG trace distortion Specific models and software versions affected.
Manufactured by Philips Healthcare: Error messages reporting a damaged or incorrectly functioning cable can trigger automatic corrective filtering of the ECG trace, distorting the ST segment, leading to risk of misinterpretation or misdiagnosis. (MDA/2017/031)
-
All Accu-Chek® Insight insulin pumps – risk of alarm failure
Manufactured by Roche Diabetes Care – the audible and/or vibration alarms might not function, which may lead to hyperglycaemia if the user doesn’t see the notification message on the pump.
-
Lung ventilators: Astral 100, 100SC and 150 – potential power loss due to faulty battery
Manufactured by ResMed – If operated only by the internal battery and this fails, the patient will not be ventilated.
-
Replacement bileaflet mechanical heart valves – risk of inverted implantation
Specific manufacturers – measures to prevent inverted valve implantation resulting from incorrect mounting of the valve on its valve holder.
-
Intra-aortic balloon pump (IABP): CS100, CS100i and CS300 – risk of haemodynamic instability to patients with critical conditions due to a delay in or sudden interruption of therapy
Manufactured by Datascope Corp – an electrical fault caused by a solenoid valve could mean the device fails to start or deliver therapy to patients (MDA/2017/027)
-
Overhead hoist: Freeway Easy Fit system with a swivelling trolley – risk of fixing pin moving or splaying
Manufactured by Prism – splayed or misplaced pins may lead to the hoop detaching and dropping the sling.
-
Nail intramedullary fixation system: Trauma guide wires 70cm – risk of infection
Manufactured by Zimmer Biomet – Recall due to risk of infection if the wire breaks through the packaging (MDA/2017/025)
-
Insulin pens: NovoPen Echo and NovoPen 5 (certain batches) – risk of hyperglycaemia due to cartridge holder weakening when exposed to certain household chemicals
Manufactured by Novo Nordisk - recall and replacement of specific batches of cartridge holder (MDA/2017/024)
-
Shoulder system: Comprehensive Nano Humeral Components – increased risk of revision when used in reverse configuration
Manufactured by Zimmer Biomet – do not use this device in the reverse configuration. (MDA/2017/023)
-
DePuy Synthes Impactor for PFNA (Proximal Femoral Nail Anti-rotation) Blade: risk of infection
Manufactured by Synthes GmbH – Recall due to risk of infection from cracked weld of the handle.
-
VITEK®2 Identification (ID) / Antimicrobial Susceptibility Test (AST) Cards – potential false resistance for antibiotics on the AST panel, leading to false negative ESBL test or false positive urea (URE) reaction on ID cards
Manufactured by BioMérieux – due to a manufacturing issue, some test card pouches might be damaged, resulting in antibiotic degradation.
-
Haemofiltration machine: all Prismaflex systems installed with software version 6.10 – risk of under-infusion of anticoagulant
Manufactured by Baxter – the software fails to save the syringe type and size in service and custom modes, and so reverts to default settings.
-
Unomedical high concentration oxygen masks (specific lots) - risk of hypoxia as the tubing can disconnect from the oxygen mask
Manufactured by ConvaTec – due to a manufacturing fault, the tubing may disconnect from the oxygen mask, prior to use or during use, causing a disruption in the supply of oxygen to patients (MDA/2017/019)
-
All metal-on-metal (MoM) hip replacements: updated advice for follow-up of patients
MHRA is updating advice provided in MDA/2012/036, to assist the early detection of soft tissue reactions in patients implanted with metal-on-metal (MoM) hip replacements (MDA/2017/018)
-
BVM (Bag-Valve-Mask) manual resuscitation systems – risk of delay to emergency treatment
Manufactured by Intersurgical – due to a manufacturing fault, the valve may become stuck during storage, leading to the intended tidal volume not being delivered and a delay to treatment.
-
DePuy Synthes Radial Head elbow prosthesis system: risk of post-operative loosening of the radial stem
Manufactured by Synthes GmbH - Recall of Radial Head Prosthesis System.
-
Solus Flexible Wire Reinforced Laryngeal Mask Airway – risk of hypoxia due to partial or total occlusion of the airway tube after inflating the cuff
Manufactured by Intersurgical – due to a manufacturing fault, inflation of the cuff may reduce the airway tube cross-section, leading to partial or total occlusion of the airway and reduced air flow to the patient.
-
All HeartStart MRx defibrillators – possible failure to deliver a shock, cardioversion, pacing or monitoring
Manufactured by Philips Healthcare – two battery related problems: 1) may fail to power on or reboots repetitively, 2) after unplugging from AC mains, may fail to deliver a shock or undertake pacing.
-
All LIFEPAK 1000 automatic external defibrillators (AEDs) - risk of device shutting down unexpectedly during patient treatment and possible failure to deliver therapy
Manufactured by Physio-Control – risk of unexpected device shutdown due to an intermittent connection between the battery and device contacts.
-
V60 ventilator – potential for unexpected shutdown
Manufactured by Philips Respironics – faulty software can cause false alarms for stalled blower motor, leading to unexpected shutdown
-
Biological replacement pericardial aortic heart valve: Mitroflow LX (sizes 19mm and 21mm) – risk of early structural valve deterioration
Manufactured by LivaNova – increased risk of earlier than anticipated structural valve deterioration (SVD) particularly with the smaller sizes.
-
All Accu-Chek® Insight insulin pumps – updated information for battery management
Manufactured by Roche Diabetes Care – Replacement and update to MDA/2015/029 with new instructions to improve battery lifetime and prevent unexpected pump shut down or rapid battery depletion.
-
BD Plastipak 100ml catheter tip syringe with Luer slip adaptor, specific lots – risk of leakage and delayed therapy
Manufactured by Becton Dickinson (BD) – product recall due to leak around the stopper which can result in under-dose or exposure of clinicians or patients to cytotoxic drugs.
-
LMA mucosal atomization devices - topical anaesthesia may not be delivered in a fully atomised spray
Manufactured by Teleflex – Poor atomisation of the spray could result in inadequate topical anaesthesia delivery, which may lead to discomfort or difficulties delivering anaesthesia