Product defect correction: Medfusion syringe pump models 3500 & 4000, eight issues

ANZCA has become aware of a product defect correction for eight issues in Medfusion syringe pump models 3500 and 4000, from Smiths Medical. Several issues could potentially cause serious injury or death. The issues are:

1. False alarm for Primary Audible Alarm (PAA) system failure.
2. Unanticipated depleted battery alarms.
3. Abnormal circuit board behaviour may cause internal clock system failure.
4. Intermittent Volume Over Time (IVOT) delivery mode - infusion continues after system failure.
5. Clearing of Program Volume Delivered (PVD).
6. False alarm for rate below recommended minimum for syringe size.
7. Incorrect bolus or loading dose time display.
8. Network configuration may affect pump communications.

Smiths Medical has contacted owners and advised them to remove and quarantine the device from use. Software updates will be available in the next 12 months.

More information is available from the Therapeutic Goods Administration Australia recall listing or Medsafe New Zealand recall listing.