Device Recall Baxter SIGMA Spectrum Infusion Pump with Master Drug Library 의 리콜

Recall

76364

Class 2

Z-1693-2017

2017-01-26

Terminated

United States

2018-05-24

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152976

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.

URGENT MEDICAL DEVICE CORRECTION Letters and Reply Forms (dated 1/26/2017) were mailed to customers via USPS first-class mail on 1/26/2017 providing the necessary instructions to customers. For questions, please contact your Baxter sales representative, or Baxter Healthcare Medina at 800-356-3454 (choose option 1) Monday through Friday, between 7:00 am and 7:00 pm ET.