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181 alerts for Medical device alert
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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.
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Heater-cooler devices used in cardiac surgery – risk of infection with Mycobacterium species update
Updated advice from manufacturers on device management for systems known or suspected to be contaminated with Mycobacterium chimaera.
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Medical device alerts archived in October 2016
A list of all medical device alerts that were archived in October 2016.
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Total intravenous anaesthesia sets (TIVA) – risk of leakage during use
Manufactured by Global Components Medical Ltd – if propofol leaks from the check valve Luer lock connector patients could become aware during surgery (MDA/2016/021)
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Managing diabetes: patients should not change their insulin delivery device without checking with their healthcare specialist
If patients are contacted directly by a manufacturer or other organisation to try using a different insulin therapy system they should first discuss this with their diabetes specialist to avoid risk of hyperglycaemia, hypoglycaemia or diabetic ketoacidosis.
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Implantable cardioverter defibrillators (ICD) and cardiac resynchronisation therapy devices (CRT-D) – risk of loss of therapy due to rapid battery depletion
Manufactured by St Jude Medical – risk of unpredictable, rapid battery depletion leading to potential device failure and loss of therapy.
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Automatic external defibrillator (AED) LIFEPAK CR Plus and LIFEPAK EXPRESS – risk of failure to deliver a shock.
Manufactured by Physio-Control – risk of delay to defibrillation due to an intermittent component failure.
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AIRVO™2 and myAIRVO™2 humidifier – risk of undetected auditory alarm
Manufactured by Fisher & Paykel Healthcare Ltd – updated instructions for use to check the speaker before each use as undetected auditory alarms could result in the patient becoming hypoxic.
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Accu-Chek® Insight Insulin pump system: risk of over- or under-infusion of insulin
Manufactured by Roche Diabetes Care - inadequately detailed handling instructions of the 'Key Lock' function of the pump may lead to unintentional operation, which could result in rapid and severe deterioration of health e.g. hypoglycaemia or diabetic ketoacidosis.
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Accu-Chek® Insight insulin pump system manufactured by Roche Diabetes Care with NovoRapid® PumpCart® cartridges – risk of hyperglycaemia
Cartridges inserted incorrectly can leak insulin into the cartridge compartment, resulting in an under-delivery of insulin, which may lead to rapid deterioration of health, diabetic ketoacidosis or death.
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Home use blood glucose monitoring system: TRUEresult and TRUEtrack blood glucose test strips – risk of false low blood glucose results.
Manufactured by Nipro Diagnostics, certain lots of test strips may give incorrect low blood glucose results that could lead to undetected hyperglycaemia. This Alert refers to different blood glucose test strips to those covered by MDA/2016/009R.
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SerenoCem Granules - risk of bone reabsorbtion around granules
Manufactured by Corinthian Surgical Ltd - risk of bone reabsorbtion around granules implanted in the middle ear (MDA/2016/013)
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VentStar Oxylog3000F (P) 190 Disposable paediatric ventilation circuit for Oxylog 3000 and Oxylog 3000 plus ventilators – risk of rebreathing exhaled gases
Manufactured by Draeger Medical – Return ventilation circuits manufactured up to and including March 2016 as they may leak at the check valve.
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Babytherm® 8004/8010 Infant Warmer, manufactured by Drägerwerk AG & Co – risk of fire
In skin-temperature control mode, if the temperature sensor is not connected or detaches from the patient, the heating element may overheat causing particles to detach; potentially leading to fire and patient harm or death.
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RightSign HIV 1.2.O Rapid Test Cassette, HCV Rapid Test Cassette & HBsAg Rapid Test Cassette – devices may give incorrect results that could lead to a missed diagnosis.
Manufactured by Hangzhou Biotest Biotech Co Ltd: certain lots of these devices may give an incorrect false negative or false positive result when testing for HIV, HCV and HBV. These are point of care tests intended for use ONLY in professional clinical settings.
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Medical device alerts archived in July 2016
A list of all medical device alerts that were archived in July 2016.
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Reissue: Nipro Diagnostics TRUEyou blood glucose test strips - risk of false low blood glucose results in some batches
Reissued - manufacturer's telephone number amended: (Nipro Diagnostics) TRUEyou blood glucose test strips - certain lots of test strips may give incorrect low blood glucose results that could lead to undetected hyperglycaemia (MDA/2016/009R)
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Siemens ADVIA Chemistry and Dimension/Dimension Vista products – risk of false low results due to interference with N-acetylcysteine
False low results may occur in a range of clinical chemistry tests in specimens drawn from patients treated with N-acetylcysteine (NAC) due to the interference with specific assays utilised by Siemens ADVIA instruments.
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Four Bipolar QuickSite and QuickFlex lead models – risk of worsening heart failure symptoms due to wear and/or abrasion of lead insulation after implantation
Change to 2012 advice – current data supports the withdrawal of MDA/2012/021 and reversion to normal 6-monthly patient follow-up, combined with the remaining advice already given, listed under Action.
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CADD® administration sets with Flow Stop free-flow protection manufactured by Smiths Medical ASD – risk of under-infusion
All devices with an expiration date on or before 31 March 2021 are at risk of under-infusing so we advise users to undertake a risk assessment before using them. (MDA/2016/006)