PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: April 5, 2017 Initiated: January 26, 2017 #Z-1693-2017

Product Description

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

Reason for Recall

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.

Details

Units Affected
Domestic: 14,175 units; Canada: 187 units
Distribution
Natiowide, Puerto Rico and Canada
Location
Medina, NY

Frequently Asked Questions

What product was recalled?
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2. Recalled by Baxter Healthcare Corporation. Units affected: Domestic: 14,175 units; Canada: 187 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 5, 2017. Severity: Moderate. Recall number: Z-1693-2017.