Device product
SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.
Z-0197-2014
Product summary
- Event
- Event 66120
- Status
- Terminated
- Classification
- Class II
- Quantity
- 273,835 units
- Official record key
device-enforcement:Z-0197-2014
Official wording
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.
Code information: Product Code: 35700BAX, 35700ABB Serial Numbers: All
Distribution pattern: Worldwide Distribution-USA including Puerto Rico and Canada.
Derived failure modes
-
Unknown
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.