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176 alerts for Medical device alert
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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.
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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)
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Medical device alerts archived in March 2018
Following our latest review of medical device alerts, we have archived the ones listed below.
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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)
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Aquilon series of nebulisers – CE mark withdrawn and supply ceased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).
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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).
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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).
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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.
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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.
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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.
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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.
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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)
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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.
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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).
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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)
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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)
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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.
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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
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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)
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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.
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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.
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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.
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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)
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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.
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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)
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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)
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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)
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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.
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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.
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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.
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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)
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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)
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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.
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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.
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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.
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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.
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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.
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V60 ventilator – potential for unexpected shutdown
Manufactured by Philips Respironics – faulty software can cause false alarms for stalled blower motor, leading to unexpected shutdown
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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.
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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.
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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.
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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
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LMA® MAD Nasal™ intranasal mucosal atomization device – might not deliver a fully atomised plume of medication
Manufactured by Teleflex – failure of the device to deliver an atomised plume may impair the effectiveness of the medication, potentially resulting in serious injury or a life-threatening situation
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All Alaris™ GS, GH, CC, TIVA, PK, Enteral Syringe Pumps, and, Asena™ GS, GH, CC, TIVA, PK, Syringe Pumps – risk of uncontrolled bolus of medicine
Manufactured by CareFusion/BD Medical – identify and replace broken backplate spring in the plunger assembly and note updated preventative maintenance schedule for these pumps
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Comprehensive Reverse Titanium Shoulder Tray (specific lots) - risk of device fracture
Manufactured by Zimmer Biomet - recall due to increased risk of fracture for all titanium trays manufactured before September 2011 and distributed in the UK between September 2010 and January 2017.
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CARDIOSAVE Hybrid intra-aortic balloon pump (IABP) and CARDIOSAVE Rescue IABP – damaged lithium ion batteries may give off smoke, a bad smell or produce sparks
Manufactured by Maquet – until storage cases are available, avoid carrying spare batteries when transporting the IABP to reduce the risk of dropping and damaging them.
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Alaris® syringe pumps (GH, CC, TIVA & PK models) – risk of uncontrolled bolus of medicine.
[Archived] Manufactured by CareFusion – Updates and replaces MDA/2016/023 as the manufacturer has now identified the potential for unintended bolus of medication when any syringe type is used in a pump that contains a broken spring in the plunger assembly.
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Reflection® dead blow mallet (all batches) – risk of exposure to lead particles
Manufactured by Smith & Nephew – cracking of the welds on the head of the mallet can result in lead particles escaping and entering the surgical wound, potentially resulting in effects associated with lead exposure.
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Oxylog 3000 and Oxylog 3000 plus ventilator – risk of failure
Manufactured by Dräger – ventilator may stop working if oxide layers accumulate due to the infrequent use of the control knobs (potentiometers).
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Medical device alerts archived in January 2017
Following our latest review of medical device alerts, we have archived the ones listed below.