BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA SPECTRUM INFUSION PUMP

    MDR report key: 21337705 · Received February 7, 2025

    Report

    Report Number
    1314492-2025-00147
    Event Type
    Malfunction
    Date Received
    February 7, 2025
    Date of Event
    December 30, 2024
    Report Date
    February 7, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    UDI-DI
    00085412498683
    PMA / PMN Number
    K133801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FOR EVALUATION. DURING EVALUATION, THE DEVICE FIRST SOFT KEY, ON/OFF KEY, 0/BA. AND "." KEYS WERE UNRESPONSIVE. A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE CAUSE WAS IDENTIFIED TO BE KEYPAD WHICH REQUIRES REPLACEMENT TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    DURING EVALUATION OF A RETURNED SPECTRUM PUMP, THE DEVICE HAD THE FIRST SOFT KEY, ON/OFF KEY, 0/BA. AND "." KEYS WERE UNRESPONSIVE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100391 SIGMA SPECTRUM INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION 35700BAX2 NA 00085412498683

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown