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Type of Product Medical Device
TGA Recall Reference RC-2022-RN-00572-1
Product Name/Description Medfusion syringe pump

Models 3500 and 4000

ARTG 122405
(Smiths Medical Australasia Pty Ltd - Infusion pump, syringe)
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 11/05/2022
Responsible Entity Smiths Medical Australasia Pty Ltd
Reason/Issue Smiths Medical has identified 8 issues occurring across Medfusion Syringe pumps.

Multiple issues have been identified with the potential to cause serious injury or death. To date, Smiths Medical has received reports of two serious injuries and one death potentially related to one of the issues.

These issues identified 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
Recall Action Product Defect Correction
Recall Action Instructions Smiths Medical will contact customers notifying them of the need to quarantine the Medfusion Syringe Infusion Pump until the required software updates are available in the next 12 months.
Contact Information - George Koumantakis