Recall Z-0197-2014 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.
| Date | Nov 8, 2013 (initiated Jun 10, 2013) |
| Status | Terminated |
| Reason | Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion Pump with Master Drug Drug Library due to reports of upstream occlusion alarms and air-in-line alarms occurring during infusions. |
| Root cause | Process design |
| Action | On June 10, 2013 Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion Pump with Master Drug Library. The notices were dated June 5, 2013 and were distributed via first class mail. Until further information is provided, users should continue to follow the SIGMA SPECTRUM Infusion Pump Operator's Manual, which identifies a number of environmental and clinical usage factors that contribute to upstream occlusion and air-in-line alarms. For high-risk patients, consider having additional devices as backup. If the biomedical engineer finds that the senso |
| Quantity | 273,835 units |
| Distribution | Worldwide Distribution-USA including Puerto Rico and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042121 | SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY Sigma Intl., Aug 26, 2004 |