BEUDAMED
    FDA Adverse Event Death Summary report: N

    TANDEMHEART SYSTEM

    MDR report key: 1406030 · Received June 18, 2009

    Report

    Report Number
    2531527-2009-00004
    Event Type
    Death
    Date Received
    June 18, 2009
    Date of Event
    May 21, 2009
    Report Date
    June 16, 2009
    Manufacturer
    CARDIAC ASSIST INC.
    Product Code
    KFM
    PMA / PMN Number
    K991783
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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, THE TANDEMHEART CONTROLLER, PUMP, AND CANNULA WERE ALL USED IN ACCORDANCE WITH THE RECOMMENDED PRACTICES. NO MALFUNCTION OF ANY OF THE COMPONENTS OF THE TANDEMHEART SYSTEM WERE 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

    CARDIACASSIST WAS NOTIFIED BY THE HOSPITAL STAFF OF A PATIENT DEATH THAT HAD OCCURRED APPROXIMATELY 10 DAYS EARLIER. AT THE TIME OF THE INCIDENT, CIRCULATORY SUPPORT WAS BEING PROVIDED BY THE TANDEMHEART SYSTEM. CARDIACASSIST WAS INFORMED THAT THE HOSPITAL SUPPLIED ARTERIAL CANNULA BEING USED WITH THE TANDEMHEART SYSTEM BECAME DISLODGED, RESULTING IN THE EXSANGUINATION AND DEATH OF THE PATIENT. PRIOR TO THE INCIDENT, THE PATIENT HAD BEEN AWAKE AND TALKING. THE HOSPITAL SUPPLIED ARTERIAL CANNULA WAS SUTURED IN PLACE AND BELIEVED TO BE SECURE PRIOR TO THE INCIDENT.

    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 Death MEDTRONIC BIOMEDICUS FEMORAL ARTERIAL CANNULA