| 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 |
|
| 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.
This action has been closed out on 27/08/2024 |
| Contact Information |
george.koumantakis@smiths-medical.com - George Koumantakis |