Medical Device Alerts - MDA's - 2016 - 2017

The following Medical Device Alerts were issued in 2016 & 2017

2016 - 2017

Reference  Date of Issue  Title 
MDA-2017-037 21 December 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 December 2017 Syringe pumps – required user actions in the event of PL3 alarm to prevent risk of interrupted infusion
MDA-2017-035 19 December 2017 Nasogastric (NG) feeding tubes – recall due to risk of neonatal or paediatric patient choking on ENFIT connector cap
MDA-2017-034 23 November 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 Configeration 
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 
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
MDA-2016-0023 22 December 2016 Alaris syringe pumps (all models) – risk of uncontrolled bolus of medicine with non-recommended syringes.
MDA-2016-0022 13 December 2016 Heater-cooler devices used in cardiac surgery - risk of infection with Mycobacterium species.
MDA-2016-0021 27 October 2016 Total intravenous anaesthesia sets (TIVA) – risk of leakage during use - Manufactured by Global Components Medical Ltd
MDA-2016-0020 26 October 2016 Managing diabetes: patients should not change their insulin delivery device without checking with their healthcare specialist.
MDA-2016-0019 17 October 2016 Implantable cardioverter defibrillators (ICD) and cardiac resynchronisation therapy devices (CRT-D) – Manufactured by St Jude Medical – risk of unpredictable, rapid battery depletion leading to potential device failure and loss of therapy.
MDA-2016-0018 13 October 2016 Automatic external defibrillator (AED) LIFEPAK CR Plus and LIFEPAK EXPRESS, manufactured by Physio-Control – risk of delay to defibrillation due to an intermittent component failure. Specific serial numbers are affected.
MDA-2016-0016 1 September 2016 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.
MDA-2016-007 24 May 2016 Bipolar Quicksite And Quickflex Lead Model’s: 1056t, 1058t, 1156t and 1158t Manufactured By St Jude Medical. Risk Of Worsening Heart Failure Symptoms Due To Wear And/Or Abrasion Of Lead Insulation After Implantation.
MDA-2016-002 03 March 2016 Ambulatory syringe pumps (T34 and T60) and syringe extension sets used with the T34 pump, manufactured by Caesarea Medical Electronics (CME).

 

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