BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM IQ INFUSION PUMP

    MDR report key: 14625842 · Received June 7, 2022

    Report

    Report Number
    1314492-2022-02324
    Event Type
    Injury
    Date Received
    June 7, 2022
    Date of Event
    November 16, 2021
    Report Date
    June 7, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K173084
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER FACILITY SUBMITTED MEDWATCH MW5109134 FOR THIS EVENT. THE DEVICE WAS NOT RETURNED AND THE SERIAL NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. THIS REPORTED PROBLEM IS POTENTIALLY WITHIN SCOPE OF FA 2021-056: SPECTRUM IQ (V9) AND V8 - DEVICE SAFETY SIGNAL FOR NON-DELIVERY AND UNDETECTED UPSTREAM OCCLUSION. 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 INFUSION PUMP UNDER INFUSED HEPARIN DURING THERAPY AND THE PATIENT EXPERIENCED HYPOXIA. NO DRIPS WERE OBSERVED FALLING INTO THE DRIP CHAMBER AND THE BAG WAS NOTED TO STILL BE FULL DURING SHIFT CHANGE (30 ML OF HEPARIN SOLUTION WAS EXPECTED TO BE PRESENT IN THE BAG). SUBSEQUENTLY, THE PATIENT EXPERIENCED HYPOXIA AND WAS PLACED IN A PRONE POSITION AND FIO2 (FRACTION OF INSPIRED OXYGEN) AND PEEP (POSITIVE-END-EXPIRATORY PRESSURE) WERE INCREASED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656769 SPECTRUM IQ INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention HEPARIN