Medical Device Alerts - MDA's - 2019

The following Medical Device Alerts were issued in 2019.

2019

Reference Date of Issue Title
MDA-2019-001 17 January 2019 Datex-Ohmeda Aisys CS2 and Aisys anaesthesia devices with software version 11 and version 11 SP01 (Service Pack) – Risk of ventilation loss, inadequate anaesthesia and hypoxia or severe hypotension
MDA-2019-002 25 January 2019

Nellix Endovascular Aneurysm Sealing (EVAS) System - Device recall and enhanced patient surveillance

This MDA has been updated- please see MDA-2019-021 for updated guidance

MDA-2019-003 29 January 2019 FreeStyle Libre flash glucose sensor – Use of barrier methods to reduce skin reactions to the sensor adhesive
MDA-2019-004 30 January 2019 Arjo Minstrel passive floor lift (portable hoist) – risk of spreader bar detachment from lifts WITHOUT a scale
MDA-2019-005 30 January 2019 Recall of certain batches of Eurotrol haemoglobin controls due to microbial contamination
MDA-2019-006 08 February 2019 Orthopaedic implant rHead Radial Head and Uni-Elbow: risk of early loosening
MDA-2019-007 13 February 2019 Ophthalmic implant Raindrop Near Vision Inlay – risk of corneal haze
MDA-2019-008 13 February 2019 Implantable cardiac pacemakers: specific brands of dual chamber pacemakers - risk of syncope due to pause in pacing therapy
MDA-2019-009 19 February 2019 Accu-Chek® Insight insulin pumps – some need to be fitted with key frames to reduce the risk of accidentally unlocking keys or pressing the bolus buttons
MDA-2019-010 20 February 2019 Professional use monitor/defibrillator: LIFEPAK 15 – risk of device failure during patient treatment and possible failure to deliver therapy
MDA-2019-011 27 February 2019 Multi parameter patient monitors: Carescape B450, B650, B850, B20, B40, B20i, B40i, B125, B105, Dash 3000,4000,5000, Solar 8000M/i, 9500 – risk of loss of patient monitoring
MDA-2019-012 28 February 2019 Potentially breached sterile packaging of: rectal tubes, Unoversal drainage systems, SimpaVac, sterile suction connecting tubes, sterile connecting pieces, suction handles/sets (FilterFlow™/Deltaflo), oxygen catheters, sterile nasal oxygen cannulas, sterile oxygen connecting tubes, and sterile forceps
MDA-2019-013 04 March 2019 All T34 ambulatory syringe pumps need a sponge pad fitted to the battery compartment to prevent battery connection issues
MDA-2019-014 07 March 2019 All Bard urogynaecological mesh – voluntary product withdrawal, implanted devices do not need to be removed
MDA-2019-015 08 March 2019 enFlow® IV fluid and blood warmer - risk of unsafe levels of aluminium leaching from the device * Please note - This has been replaced by MDA-2019-016
MDA-2019-016 19 March 2019 enFlow® IV fluid and blood warmer - risk of unsafe levels of aluminium leaching from the device – updated safety advice from manufacturer
MDA-2019-017 20 March 2019 Pagewriter Cardiographs (TC20/30/50/70) manufactured before 20 November 2018 and Efficia Monitors (CM10/12/100/120/150) manufactured before 25 October 2018 – risk of batteries overheating or igniting
MDA-2019-018 29 March 2019 Fresenius 5008 & 5008S haemodialysis machines – low risk of inadequate fluid removal during treatment
MDA-2019-019 25 April 2019 Ethicon Curved Intraluminal Staplers – risk of failure of staple lines
MDA-2019-020 01 May 2019 Hoists: Molift Mover 180/205 mobile hoist and Molift Air ceiling hoist - all sizes of 2-point sling bars – risk of fracture of hooks in use
MDA-2019-021 01 May 2019 Updated: Nellix Endovascular Aneurysm Sealing (EVAS) System - Device recall and enhanced patient surveillance (Note: This Medical Device Alert (MDA) updates guidance previously given in MDA-2019-002 issued 25 January 2019.)
MDA-2019-022 30 May 2019 Aisys & Aisys CS2 anaesthesia devices with Et Control option & software versions 11, 11SP01 & 11SP02 – risk of patient awareness due to inadequate anaesthesia
MDA-2019-023 04 June 2019 Recommendations for ongoing use of paclitaxel drug coated balloons (DCBs) and implantable drug eluting stents (DESs) in the treatment of patients with peripheral artery disease (PAD)
MDA-2019-024 26 June 2019 BBraun Dialog+ SW versions 9.xx (excluding versions 9.18, 9.1A, 9.1B) haemodialysis machines – upgrade of software required
MDA-2019-025 02 July 2019 IntelliVue MX40 patient-worn monitors – increased power consumption and no visual or audible alarms when batteries are low
MDA-2019-026 24 July 2019 Professional use capillary blood specimen collection: BD Microtainer® tubes – risk of blood leakage and/or incorrect test results due to defective tubes
MDA-2019-027 25 July 2019 Automated external defibrillators: All Telefunken HR1 & FA1 – no valid CE certificate
MDA-2019-028 27 August 2019 Microneedling pens: Dermapen 3 and Dermapen Cryo sterile single use needle cartridge tips for: Dermapen 3 – risk of injury or infection
MDA-2019-029 12 September 2019 Deltec Gripper non-coring needles and PORT-A-CATH trays containing Gripper needles – recall due to risk of needle occlusion
MDA-2019-030 18 September 2019 All models of T34 ambulatory syringe pumps – updated cleaning advice and maintenance requirements due to the risk of fluid ingress
MDA-2019-031 30 September 2019 Kiwi Complete Vacuum Delivery System – risk of failure to achieve or maintain vacuum during use (specific lot affected)
MDA-2019-032 3 October 2019 Breathing circuit swivel elbow – recall due to risk of cracks forming before or during use
MDA-2019-033 8 October 2019 Anaesthetic face masks – Specific Intersurgical Economy 22F taper connection may be oversized and leak or disconnect from the breathing circuit
MDA-2019-034 9 October 2019 Intraoperative probe cover with long Surgi-tip – risk of infection due to manufacturing failure (specific lot numbers affected)
MDA-2019-035 9 October 2019 Rocket and NuSurgix fetal blood sampling (FBS) amnioscopes and FBS kits – stop using ethyl chloride spray during the fetal blood sampling procedure with these devices
MDA-2019-036 10 October 2019 Specific Hudson RCI Sheridan endotracheal tubes and connectors - 15 mm connector may detach from the tube before or during use
MDA-2019-037 10 October 2019 Prismaflex haemofiltration systems installed with software versions 8.10, 7.20 and lower – risk of unexpected machine shutdown during treatment
MDA-2019-038 29 October 2019 Syringe driver pumps: T34™ 3rd edition models only – stop using the pump until updated instructions for use and BodyCommTM V3.0 software are released
MDA-2019-039 31 October 2019 Professional use defibrillator/monitor: Efficia DFM100 (Model number 866199) – risk of failure to switch on or unexpected restart

 

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