BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEMHEART PUMP

    MDR report key: 3754220 · Received April 10, 2014

    Report

    Report Number
    2531527-2012-00006
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    September 15, 2012
    Report Date
    March 7, 2014
    Manufacturer
    CARDIAC ASSIST, INC.
    Product Code
    KFM
    PMA / PMN Number
    K991783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS EVENT IS BEING SUBMITTED AS A CORRECTION FOR THIS EVENT IN RESPONSE TO A 483 OBSERVATION FROM (B)(4) 2014 FOR FEI NUMBER (B)(4). ON (B)(6) 2012, MR. (B)(6) OF THE (B)(6) SUPPORT STAFF WAS NOTIFIED THAT A TANDEMHEART PUMP HAD FAILED AND STOPPED TURNING AFTER 10 DAYS OF USE. ATTEMPTS TO RESTART THE PUMP WERE UNSUCCESSFUL WITH THE CONNECTED CONTROLLER, AS WELL AS A BACK-UP CONTROLLER. A NEW PUMP WAS CUT INTO THE CIRCUIT AND WORKED JUST FINE WITH THE BACK-UP CONTROLLER. THE FIRST CONTROLLER WAS NOTED TO BE IN A SYSTEM FAILURE MODE WHEN POWERED UP, POSSIBLY DUE TO THE PUMP STOPPAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216223 TANDEMHEART PUMP NON-ROLLER HEARING BYPASS PUMP KFM CARDIAC ASSIST, INC. 5120-0000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention