Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2

Reason: SIGMA Spectrum Infusion Pumps with Master Drug Library, Software V8.00.02 contains an anomaly that may cause a Sharp Watchdog Timeout error message. Specifically, the software anomaly causes the error message only under conditions in which a message is being written to the Spectrum Infusion Pumps Event History Log (EHL), and the length of that message exactly matches the size of the available memory at the end of a memory sector. For this reason, the issue is significantly more likely to manifest when poor network maintenance results in high volumes of messages being written to the EHL.

Code information: 14,362 Serial Numbers (please contact CDRH for list of affected Serial Numbers).

Distribution pattern: Natiowide, Puerto Rico and Canada