BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM IQ INFUSION PUMP

    MDR report key: 15036488 · Received July 16, 2022

    Report

    Report Number
    1314492-2022-02985
    Event Type
    Malfunction
    Date Received
    July 16, 2022
    Report Date
    July 19, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K220417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CATALOGUE # - A PARTIAL PRODUCT CODE OF 35700 WAS PROVIDED. THE DEVICE WAS NOT RETURNED AND THE SERIAL NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION B5: IT WAS REPORTED THAT THE SPECTRUM IQ PUMP TOOK TOO LONG TO ALARM FOR AN UPSTREAM OCCLUSION ON SLOW DRIPS. H6 MEDICAL DEVICE PROBLEM CODE: SHOULD BE A070908 RATHER THAN A160105.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SPECTRUM PUMP ALARMED UPSTREAM OCCLUSION AND PROGRAMING SLOW DURING THERAPY AT THE INTENSIVE CARE UNIT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945040 SPECTRUM IQ INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown