Recall Z-1088-05 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
Baxter 6060 Multi-Therapy Infusion Pump, product code 2M9832, 606000-40, 606000-40L, 606000-40I; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60013 USA, made in Singapore
| Date | Aug 6, 2005 (initiated Jun 13, 2005) |
| Status | Terminated |
| Reason | There is an overinfusion condition in the Intermittent mode where the pump may continue to deliver at the higher dose rate instead of switching to the lower keep open rate once the first dose is completed. |
| Root cause | Other |
| Action | Baxter sent the 6/13/05 Urgent Device Correction letter to all Baxter 6060 and 6060E Infusion Pump customers to inform them of a software anomaly which allows the pump to overinfuse in the Intermittent mode of the 6060 pump if the following specific sequence of events occur: * the infusion is running in intermittent mode; * the pump is delivering at the Keep Open (KO) rate; * the pump is then powered off and on; * the clinician initiates new programming of the pump by selecting NO at the 'Resume KO Dose 1?' prompt and selecting YES at the 'Yes to Program' prompt; * the clinician powers the pum |
| Quantity | 34,000 units |
| Distribution | Nationwide and internationally to Belgium, Germany, Finland, France, the United Kingdom, Ireland, Sweden, Norway, Canada, Japan, New Zealand and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002679 | 6060 MULTI-THERAPY PUMP, MODEL 2M9832; 6060 EPIDURAL PUMP, MODEL 2L9351 Baxter Healthcare Corp, Sep 18, 2000 |