BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEMHEART PUMP KIT

    MDR report key: 13257957 · Received January 13, 2022

    Report

    Report Number
    MW5106665
    Event Type
    Injury
    Date Received
    January 13, 2022
    Date of Event
    December 27, 2021
    Report Date
    January 11, 2022
    Manufacturer
    LIVANOVA / CARDIAC ASSIST, INC.
    Product Code
    KFM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BEDSIDE NURSE WAS BATHING THE PATIENT, AND NOTICED BLOOD ON THE SHEETS OF THE BED. NO ALARMS WERE ACTIVE, AND THE PUMP WAS PERFORMING AS USUAL. UPON FURTHER INSPECTION, BLOOD WAS COMING FROM THE OUTFLOW PORTION OF THE DEVICE. THE NURSE NOTIFIED THE CHARGE NURSE, PHYSICIAN, AND CIRCULATORY SUPPORT. THE TUBING WAS PUT SECURED BY CIRCULATORY SUPPORT AND REINFORCED WITH A ZIP TIE BAND ON THE OUTFLOW PORTION OF THE DEVICE. ONGOING MONITORING OF PATIENT CONTINUED WITH NO FURTHER PUMP CONCERNS. MANUFACTURER'S CLINICAL REPRESENTATIVE WAS CALLED, AND SURVEYED THE INCIDENT. APPROVED THE SECURING OF THE OUTFLOW PORTION WITH A TIE BAND. THE OBSERVED PORTION OF TUBING THAT WAS NOTED TO BE LEAKING IS PREINSTALLED BY THE MANUFACTURER. THIS IS THE AMENDED SUBMISSION FOR THE PREVIOUS FORM (B)(4). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857580 TANDEMHEART PUMP KIT PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM LIVANOVA / CARDIAC ASSIST, INC. 5120-00000

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention