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.)

 

Back to top