Medical Device Alerts - MDA's - 2018

The following Medical Device Alerts were issued in 2018.

2018

Reference Date of Issue Title
MDA-2018-037 21 December 2018 Fabian +nCPAP evolution, Fabian Therapy evolution and Fabian HFO – Risk of total loss of patient ventilation.
MDA-2018-036 29 November 2018 Batteries for the HeartStart MRx monitor/defibrillator may fail to charge or to provide power.
MDA-2018-035 14 November 2018 All T34 ambulatory syringe pumps – update concerning battery information
MDA-2018-034 14 November 2018 Suction catheters, gastro-enteral tubes, intermittent urology catheters and sterile urine drainage bags – potential breach in sterile barrier packaging.          Additional Devices Affected - Please see MDA-2019-012
MDA-2018-033 08 October 2018 CoaguChek Test Strips for Point of Care and Home Use – risk of false high results
MDA-2018-032 24 September 2018 Various trauma guide wires – risk of infection due to packaging failure
MDA-2018-031 19 September 2018 SureSigns VS & VM patient monitors and Viewing stations manufactured before May 2018: risk of batteries overheating or igniting
MDA-2018-030 19 September 2018 Flex connectors in Halyard Closed Suction Kits – risk of interruption of ventilation
MDA-2018-029 13 September 2018 BenchMark Automated Slide Stainer series – FLO LOK III Reagent Dispenser Issue for IHC and ISH kits including INFORM HPV III Family 16 Probe (B).
MDA-2018-028 01 August 2018 Orthopaedic bone plates and cortical screws: ADVANSYS MLP-DLP; ADVANSYS TTC; Large QWIX; TIBIAXYS and UNI-CP–Sterile – Risk of infection
MDA-2018-027 26 July 2018 Breast implants, all types, makes and models – Continue to report suspected cases of Breast Implant Associated - Anaplastic Large Cell Lymphoma (BIA - ALCL)
MDA-2018-026 23 July 2018 First generation JOURNEY BCS Knee System– Higher than expected risk of revision
MDA-2018-025R 12 July 2018 Novaline haemodialysis bloodlines used with Baxter/Gambro haemodialysis machines – Recall of specific products due to various problems encountered during clinical use
MDA-2018-025 11 July 2018 Novaline haemodialysis bloodlines used with Baxter/Gambro haemodialysis machines – Recall of specific products due to various problems encountered during clinical use
MDA-2018-024R 12 July 2018 All Alaris™ and Asena™ GS, GH, CC, TIVA, PK, enteral syringe pumps – risk of uncontrolled bolus of medicine.
MDA-2018-024 11 July 2018 All Alaris™ and Asena™ GS, GH, CC, TIVA, PK, enteral syringe pumps – risk of uncontrolled bolus of medicine.
MDA-2018-023 05 July 2018 Combur10 Test UX and Chemstrip 10 A test strips – risk of falsely low results when measuring test strips on the Urisys 1100 urine analyser.
MDA-2018-022R 06 July 2018 SAM XT Extremity Tourniquet – Recall due to the risk of tourniquet failing in use
MDA-2018-022 05 July 2018 Recall due to the risk of tourniquet failing in use
MDA-2018-021 21 June 2018 Alaris Smartsite Add-On Bag Access device – removal and destruction of specific batches due to risk of disconnection or leakage
MDA-2018-020 20 June 2018 Smiths Medical CADD® Non Flow-Stop Medication Cassette Reservoirs – recall of specific lots due to risk of under delivery of medication
MDA-2018-019 11 June 2018 JM103 and JM105 Jaundice Meters – risk of misinterpretation of measurement in hyperbilirubinemia cases
MDA-2018-018 31 May 2018 Various Arrow Critical Care devices – recall due to incomplete packaging seals
MDA-2018-017 24 May 2018 Cook Vacuum Pump for IVF – risk of electric shock or burn to operator
MDA-2018-016 18 May 2018 Home use and Point of Care blood glucose monitoring system: Accu-Chek Aviva, Accu-Chek Performa and Accu-Chek Inform II test strips – risk of strip error messages and false high and low blood glucose results
MDA-2018-015 16 May 2018 Gambro Ultrafilter U9000 microbial water filter for haemodialysis – risk of hypovolemia due to filter leaks during use
MDA-2018-014 02 May 2018 Infinity Acute Care System and M540 Patient Monitors software versions VG2.2-VG6.0 – risk that alarms are not activated
MDA-2018-013 01 May 2018 cobas b 221 instruments with AutoQC module – software limitation affecting automatic QC measurements
MDA-2018-012 26 April 2018 BD Vacutainer® EDTA & BD Vacutainer® Lithium Heparin Tubes – risk of incorrect results for lead testing or other assays using ASV methodology
MDA-2018-011 20 April 2018 Bone Cement: Optipac 40 Refobacin Revision and Optipac 80 Refobacin Revision – Risk of revision
MDA-2018-010 28 March 2018 All T34 ambulatory syringe pumps – risk of unintended pump shutdown and delay to treatment
MDA-2018-009 03 March 2018 Bag valve mask (BVM) manual resuscitation system – risk of damage to lungs by delivery of excessive pressure
MDA-2018-008 22 February 2018 Aquilon series of nebulisers – CE mark withdrawn and supply ceased
MDA-2018-007 15 February 2018 Zimmer Biomet, specific hip and trauma instruments: risk of infection
MDA-2018-006 15 February 2018 Plum 360 infusion pumps – user actions required to prevent risk of interrupted infusion or delay to treatment
MDA-2018-005 15 February 2018 Roche Tissue Diagnostics (Ventana Medical Systems) – OptiView DAB IHC Detection Kit, UltraView Universal DAB Detection Kit, OptiView Amplification Kit and Hematoxylin II – Dispenser failure of Hematoxylin II and Horseradish Peroxidase reagents.
MDA-2018-004 14 February 2018 Recall of specific lots of RUSCH sensor (series 400) silicone and non-sterile rectal/ pharyngeal temperature sensors
MDA-2018-003 22 January 2018 In vitro fertilisation (IVF) and assisted reproduction technologies (ART) products - precautionary measure
MDA-2018-002 15 January 2018 All Philips HeartStart MRx monitors/defibrillators – significant delay in the supply of batteries
MDA-2018-001 12 January 2018 Pacemakers & CRT-P - oversensing of minute ventilation sensor signal leading to risk of syncope & pre-syncope

 

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