BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEMHEART PUMP KIT

    MDR report key: 13205793 · Received January 7, 2022

    Report

    Report Number
    MW5106527
    Event Type
    Injury
    Date Received
    January 7, 2022
    Date of Event
    December 27, 2021
    Report Date
    January 5, 2022
    Manufacturer
    LIVANOVA / CARDIAC ASSIST, INC.
    Product Code
    KFM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    STATEMENT FROM BEDSIDE NURSE; I (BEDSIDE NURSE) HAD BEEN BATHING MY PATIENT AND NOTICED BLOOD AT THE BOTTOM OF THE BED. NO ALARMS HAD GONE OFF, THE TANDEM PUMP WAS FUNCTIONING NORMAL. UPON FURTHER INSPECTION OF THE AREA, IT APPEARED THAT BLOOD WAS COMING OUT OF THE TANDEM PUMP AT THE OUTFLOW SITE. I GOT MY CHARGE NURSE WHO HAS 25+ YEARS EXPERIENCE TO LOOK AT THIS TANDEM WITH ME. I PUSHED THE TUBING TOGETHER TO BETTER SECURE IT AND STOP THE BLEEDING. NOTIFIED THE PHYSICIAN AND CIRC SUPPORT CAME TO THE BEDSIDE AS WELL. THEY PUT SECURE TAGS ON THE TUBING. THE CHARGE AND SAW MY PUSH THE TUBING BACK IN PLACE. AN XRAY WAS DONE AFTER TO ENSURE PROPER PLACEMENT OF TANDEM. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2476083 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