BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER SPECTRUM IQ PUMP

    MDR report key: 13846872 · Received March 21, 2022

    Report

    Report Number
    MW5108371
    Event Type
    Malfunction
    Date Received
    March 21, 2022
    Date of Event
    December 14, 2021
    Report Date
    March 17, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NO INFORMATION
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    CHEMOTHERAPY INFUSION SETTINGS CORRECT CHECKED AT BEGINNING OF INFUSION WITH 2 RN'S. LINE INFUSING BUT 1 HOUR INTO INFUSION BAG FILL LARGER THAN WOULD EXPECT. TWO (2) RN'S CHECKED SETTINGS, THEY WERE CORRECT. CHECKED WITH PHARMACIST, CONTINUE INFUSION AT CURRENT RATE. AT COMPLETION PUMP STATING 808 ML INFUSED IN A 530 ML BAG. THIS PER PHARMACY IS NOT POSSIBLE. INFUSION COMPLETED. PUMP REMOVED FROM CIRCULATION AND INFORMATION, START/STOP TIME AND AMOUNT INFUSED DOCUMENT. BAXTER PUMP (B)(4). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134755 BAXTER SPECTRUM IQ PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown