BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEMHEART SYSTEM

    MDR report key: 1944469 · Received December 17, 2010

    Report

    Report Number
    2531527-2010-00008
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    November 18, 2010
    Report Date
    December 14, 2010
    Manufacturer
    CARDIAC ASSIST, INC.
    Product Code
    KFM
    PMA / PMN Number
    K991783
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TANDEMHEART SYSTEM COMPONENTS WERE NOT RETURNED FOR EVALUATION. PER THE INFORMATION PROVIDED BY THE HOSPITAL, NO MALFUNCTION OF ANY OF THE COMPONENTS OF THE TANDEMHEART SYSTEM WAS OBSERVED. THE DISLODGEMENT OF THE ARTERIAL CANNULA, WHICH IS NOT SUPPLIED OR MANUFACTURED BY CARDIACASSIST, WAS DETERMINED TO BE THE ROOT CAUSE OF THE INCIDENT.

    Description of Event or Problem · 1

    ON (B)(6) 2010, CARDIAC ASSIST WAS NOTIFIED BY THE HOSPITAL STAFF OF AN ADVERSE EVENT THAT RESULTED IN A MODERATE PATIENT BLOOD LOSS. SUPPORT FOR THE PATIENT HAD BEEN INITIATED WITHOUT INCIDENT ON (B)(6) 2010. WHILE CHANGING THE DRESSING ON THE ARTERIAL RETURN CANNULA, THE CANNULA BECAME PARTIALLY DISLODGED, RESULTING IN HEAVY BLEEDING. THE STAFF TRIED TO REPOSITION THE ARTERIAL CANNULA, BUT WERE UNABLE TO DO SO. THE TANDEMHEART PUMP WAS STOPPED, AND DIRECT PRESSURE WAS HELD ON THE ARTERIAL CANNULA SITE TO MINIMIZE BLEEDING. THE PATIENT WAS TAKEN TO THE OPERATING ROOM TO REPAIR A FEMORAL ARTERY DISSECTION. THE PATIENT WAS AWAKE AND FOLLOWING COMMANDS AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANDEMHEART SYSTEM NON-ROLLER BEARING BYPASS PUMP KFM CARDIAC ASSIST, INC. TANDEMHEART

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention MEDTRONIC BIOMEDICUS FEMORAL ARTERIAL CANNULA