Medical Device Alerts - MDA's - 2016

The following Medical Device Alerts were issued in 2016

2016 

Reference  Date of Issue  Title 
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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