BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA SPECTRUM INFUSION PUMP

    MDR report key: 13844682 · Received March 22, 2022

    Report

    Report Number
    13844682
    Event Type
    Malfunction
    Date Received
    March 22, 2022
    Date of Event
    February 26, 2022
    Report Date
    March 11, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    UDI-DI
    00085412498683
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    VANCOMYCIN IVPB PARTIALLY INFUSED DURING PRESCRIBED TIME; PUMP DID NOT INFUSE ALL OF MEDICATION; PUMP TAGGED FOR REPAIR AND REMOVED FROM SERVICE. PASSED ALL TESTS IN HTM, SENT BACK TO BAXTER FOR REPAIR/EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891183 SIGMA SPECTRUM INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION 35700BAX2 00085412498683

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown