BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM IQ INFUSION PUMP

    MDR report key: 17126939 · Received June 14, 2023

    Report

    Report Number
    1314492-2023-02156
    Event Type
    Malfunction
    Date Received
    June 14, 2023
    Report Date
    June 14, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K222048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B3: IT WAS REPORTED THAT THE EVENT DATE WAS 23-MAY-2023 / 24-MAY-2023 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SPECTRUM IQ PUMP HAD INCREASED UPSTREAM OCCLUSION ALARM FREQUENCY POST-IMPLEMENTATION OF SOFTWARE UPDATE DURING THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197211 SPECTRUM IQ INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown