BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM QUANTUM PUREFLOW CENTRIFUGAL BLOOD PUMP HEAD

    MDR report key: 20993411 · Received December 19, 2024

    Report

    Report Number
    MW5163799
    Event Type
    Injury
    Date Received
    December 19, 2024
    Date of Event
    December 11, 2024
    Report Date
    December 17, 2024
    Manufacturer
    SPECTRUM MEDICAL INC
    Product Code
    KFM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SITUATION: DURING A CARDIAC SURGERY PROCEDURE, THE HEART/LUNG MACHINE WAS STARTED TO SUPPORT THE PATIENT'S CIRCULATION. WITHIN 5 MINUTES OF USE, THE PUMP THAT PRODUCES BLOOD FLOW STARTED MAKING A RATTLING NOISE BUT CONTINUED TO GENERATE NORMAL BLOOD FLOW. BACKGROUND/RISK FACTORS: THE BLOOD PUMP PROVIDES CIRCULATION TO KEEP THE PATIENT ALIVE DURING THE SURGICAL PROCEDURE ASSESSMENT: THE PUMP HEAD WAS INSPECTED AND RESET ON THE DRIVE MOTOR, BUT THE RATTLING SOUND RETURNED WITHIN 5 MINUTES. IT WAS IMMEDIATELY DECIDED TO CHANGE THE DISPOSABLE PUMP HEAD. RESPONSE/INTERVENTIONS: THE PATIENT WAS WEANED FROM THE HEART/LUNG MACHINE, WHILE MAINTAINING STABLE VITAL SIGNS THROUGHOUT. THE PUMP HEAD WAS CHANGED AND THE PROCEDURE RESUMED WITHOUT INCIDENT. THE DEFECTIVE PUMP HEAD SAVED AND SENT TO THE MANUFACTURER FOR EVALUATION. WE VOLUNTARILY REMOVED OTHER PUMP HEADS WITH THE SAME LOT # FROM USE AT OUR FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2627836 SPECTRUM QUANTUM PUREFLOW CENTRIFUGAL BLOOD PUMP HEAD PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM SPECTRUM MEDICAL INC CP37V-V0 G001361

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention