| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00314-1 |
| Product Name/Description |
Arcomed Volumed µVP7000 Infusion Pump
ARTG Number: 279584
(Admedus Australia - Infusion pump, general-purpose) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, Arcomed AG, has been informed that in some rare cases the Volumed µVP7000 did not perform within the specified volumetric accuracy with PVC lines due to low door pressure. A deviation of the infused volume can have a negative impact on the patient.
The pumps do perform an initial stop flow test that also tests the door pressure, however in rare occasions pumps would still not perform within the specified tolerances after passing the stop flow test.
Admedus Australia, following consultation with the manufacturer, have developed a 'Strip Test" to be included in the standard preventative maintenance testing procedures, which are used to check that the machines are operating in accordance with specifications. The Strip Test will check devices for mechanical tolerances of the door which will increase the safety tolerances of the device. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Admedus is advising customers to add the replacement page provided with the Customer Letter to the user manual of the device. Users should continue to monitor operation of the pumps and arrange for the pump to be checked by a trained service engineer if they notice any volumetric inaccuracies (note: small deviations within the specifications (5%) may occur).
Service Technicians are being provided a replacement page for the service manual instructing how to perform the 'Strip Test'.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1300 550 310 - Admedus Customer Service |