| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00384-1 |
| Product Name/Description |
Colleague Volumetric Infusion Pumps
Product Codes: 2M91617 & 2M91637
ARTG Number: 177494 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
31/03/2014 |
| Responsible Entity |
|
| Reason/Issue |
During 2011, it was identified that a quantity of pumps fitted with two ceramic 1.6A slow-blow fuses in the rear housing was failing prematurely. Investigation led to a change of the fuse type fitted during future manufacture and service, from a ceramic fuse to a glass fuse, which has a different rupture characteristic. The failure rate of this reported issue has subsequently declined following the replacement with a glass fuse in newly manufactured pumps. If the fuses fail the device cannot charge the batteries even when connected to A.C. power. Failure of the fuses while the pump is in operation would result in the pump switching from A.C. power to battery power and the A.C. icon would extinguish. The pump would continue to run on battery power with corresponding battery discharge alarms. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers are asked to examine the two fuses installed in the rear of the pump which can be accessed by slotted fuse covers to establish if the fuses are glass or ceramic type. Ceramic fuses should be replaced with the glass fuses which will be supplied by Baxter. For Baxter owned pumps placed with customers, Baxter will carry out this activity at the next service. |
| Contact Information |
02 9848 1111 - Baxter Healthcare |