Medical Device Alerts - MDA's - 2017

The following Medical Device Alerts were issued in 2017.

2017

Reference Date of Issue Title
MDA-2017-037 21/12/2017 AlterG Anti-Gravity treadmill, model M320, used for rehabilitation after surgery – unexpected surge to maximum speed and failure of the emergency stop
MDA-2017-036 20/12/2017 Syringe pumps – required user actions in the event of PL3 alarm to prevent risk of interrupted infusion
MDA-2017-035 19/12/2017 Nasogastric (NG) feeding tubes – recall due to risk of neonatal or paediatric patient choking on ENFIT connector cap
MDA-2017-034 23/11/2017 ThermoScientificTM OxoidTM CAZ10 ceftazidime, CT1629B antimicrobial susceptibility test disc – potential for false resistance results if stored at the wrong temperature
MDA-2017-033 03 October 2017 Professional use HIV test: Alere HIV Combo – risk of false positive results
MDA-2017-032 03 October 2017 Intra-aortic balloon pump (IABP): Maquet/Datascope CS100, CS100i and CS300 – potential for interruption or delay to therapy of critically ill patients
MDA-2017-031 29 September 2017 Philips Healthcare: IntelliVue patient monitors used with 12-lead ECG – risk of ECG trace distortion Specific models and software versions affected.
MDA-2017-030 20 September 2017 All Accu-Chek® Insight insulin pumps – risk of alarm failure
MDA-2017-029 12 September 2017 Lung ventilators: Astral 100, 100SC and 150 – potential power loss due to faulty battery
MDA-2017-028 31 August 2017 Replacement bileaflet mechanical heart valves – risk of inverted implantation
MDA-2017-027 24 August 2017 Intra-Aortic Balloon Pump (IABP) – risk of hemodynamic instability to patients
MDA-2017-026 24 August 2017 Prism - Freeway Easy Fit system with a swivelling trolley – risk of fixing pin moving or splaying
MDA-2017-025 24 August 2017 Zimmer Biomet - Nail intramedullary fixation system: Trauma guide wires 70cm – risk of infection
MDA-2017-024 24 August 2017 Novo Nordisk NovoPen Echo & NovoPen 5 – Risk of hyperglycaemia
MDA-2017-023 18 August 2017

Shoulder system: Comprehensive Nano Humeral Components – increased risk of revision when used in reverse configuration

MDA-2017-022 17 August 2017 DePuy Synthes Impactor for PFNA (Proximal Femoral Nail Anti-rotation) Blade: risk of infection
MDA-2017-021 14 August 2017 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 in ID Cards
MDA-2017-020 11 July 2017 Haemofiltration machine: all Prismaflex systems installed with software version 6.10 – risk of under-infusion of anticoagulant
MDA-2017-019 10 July 2017 Unomedical high concentration oxygen masks (specific lots) - risk of hypoxia as the tubing can disconnect from the oxygen mask
MDA-2017-018 29 June 2017 All metal-on-metal (MoM) hip replacements: updated advice for follow-up of patients
MDA-2017-017 21 June 2017 Intersurgical - BVM (Bag-Valve-Mask) manual resuscitation systems – risk of delay to emergency treatment
MDA-2017-016 12 June 2017 DePuy-Synthes Radial Head Elbow Prosthesis System, Risk of Post-Operative Loosening of Radial Stem
MDA-2017-015 09 June 2017 Solus Laryngeal Mask Airway – risk of partial or total occlusion of the airway after inflating cuff
MDA-2017 - 014 24 May 2017 All HeartStart MRx defibrillators – possible failure to deliver a shock, cardioversion, pacing or monitoring
MDA-2017-013 18 May 2017 All LIFEPAK 1000 automatic external defibrillators (AEDs) - risk of device shutting down unexpectedly during patient treatment and possible failure to deliver therapy.
MDA-2017-012 17 May 2017 V60 ventilator – potential for unexpected shutdown.
MDA-2017-011 03 May 2017 Biological replacement pericardial aortic heart valve: Mitroflow LX (sizes 19mm and 21mm) – risk of early structural valve deterioration
MDA-2017-010 02 May 2017 All Accu-Chek® Insight insulin pumps – updated information for battery management.
MDA-2017-009 24 April 2017 BD Plastipak 100ml catheter tip syringe with Luer slip adaptor, specific lots – risk of leakage and delayed therapy
MDA-2017-008 24 April 2017 Teleflex – Poor atomisation of the spray could result in inadequate topical anaesthesia delivery, which may lead to discomfort or difficulties delivering anaesthesia
MDA-2017-007 21 April 2017 Teleflex - LMA, MAD Nasal intranasal mucosal atomization device – might not deliver a fully atomised plume of medication
MDA-2017-006 12 April 2017 All Alaris™ GS, GH, CC, TIVA, PK, enteral syringe pumps & Asena™ GS, GH, CC, TIVA, PK, syringe pumps  – risk of uncontrolled bolus of medicine
MDA-2017-005 04 April 2017 Comprehensive Reverse Titanium Shoulder Tray - Risk of Device Fracture
MDA-2017-004 07 March 2017

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.

MDA-2017-003 20 February 2017 Alaris Syringe Pumps (GH, CC, TIVA & PK Models) – Risk of Uncontrolled Bolus of Medicine.
MDA-2017-002 17 February 2017 Reflection Dead Blow Mallet (All Batches) – Risk of Exposure to Lead Particles
MDA-2017-001 08 February 2017 Oxylog 3000 and Oxylog 3000 Plus Ventilator – Risk of Failure.

 

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