BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEMHEART PUMP

    MDR report key: 1113324 · Received August 12, 2008

    Report

    Report Number
    2531527-2008-00007
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    July 3, 2008
    Report Date
    August 4, 2008
    Manufacturer
    CARDIACASSIST, INC.
    Product Code
    KFM
    PMA / PMN Number
    K991783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: BOTH THE PUMP AND CONTROLLER INVOLVED IN THE INCIDENT WERE RETURNED FOR ASSESSMENT. FAILURE ANALYSIS OF THE PUMP WAS UNABLE TO CONFIRM THE REPORTED ISSUE. THE VISUAL EXAMINATION OF THE PUMP FOUND NO DAMAGE OR DEFECTS. ELECTRICAL AND FUNCTIONAL TESTS OF THE PUMP CONFIRMED THAT IT WAS OPERATING WITHIN SPECIFICATION. THE INTERNAL EXAMINATION OF THE PUMP FOUND NO DAMAGE OR ABNORMAL WEAR. FAILURE ANALYSIS OF THE CONTROLLER CONFIRMED THE PRESENCE OF THE ALARM MESSAGE, BUT NO DAMAGE OR DEFECTS ON THE CONTROLLER WERE FOUND. THE CONTROLLER WAS TESTED FUNCTIONALLY OVER A PERIOD OF 7 DAYS, FOUND TO BE OPERATING WITHIN SPECIFICATION. NO CAUSE FOR THE INCIDENT COULD BE ESTABLISHED.

    Description of Event or Problem · 1

    APPROXIMATELY 3 HOURS AFTER SUPPORT WAS INITIATED, A LOSS OF FLOW WAS NOTED AND THE CONTROLLER DISPLAYED AN ALARM MESSAGE. THE CLINICIANS REPLACED THE PUMP TO CORRECT THE ISSUE. THE PATIENT WAS NOT ADVERSELY IMPACTED BY THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANDEMHEART PUMP NON-ROLLER TYPE BYPASS PUMP KFM CARDIACASSIST, INC. TANDEMHEART

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention