—#152976

Product

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

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K133801
Affected lot / code info: 14,362 Serial Numbers (please contact CDRH for list of affected Serial Numbers).

Why it was 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.

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 711 Park Ave, Medina, New York 14103-1036

Distribution

Distribution pattern: Natiowide, Puerto Rico and Canada

Timeline

Recall initiated: 2017-01-26
Terminated: 2018-05-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #152976. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.