BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 3180204 · Received June 13, 2013

    Report

    Report Number
    2916596-2013-00772
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR (VC) REPORTED THAT WHEN THE SYSTEM CONTROLLER WAS INITIALLY PLUGGED INTO THE POWER MODULE PT CABLE DURING PUMP PREP TO BURN THE MOTOR IN, IT DID NOT BEHAVE APPROPRIATELY. WHEN IT BEGAN TO ALARM, THE VC PRESSED THE "SILENCE ALARM" BUTTON; HOWEVER, THE ALARM WOULD NOT SILENCE. THE BUTTON DISAPPEARED WHICH LEAD THE VC TO BELIEVE SHE PRESSED THE BUTTON CORRECTLY, BUT IT CONTINUED TO ALARM. IT WOULD NOT SILENCE UNTIL THE VC TURNED ON THE "EXTENDED SILENCE" ALARM DUE TO THE STERILE AREA BEING CONTAMINATED, THE VC DISCONNECTED THE SYSTEM CONTROLLER FROM THE POWER MODULE (PM) AND RECONNECTED IT. AGAIN, IT WOULD NOT SILENCE WHEN THE BUTTON WAS PRESSED, BUT DID WHEN THE EXTENDED SILENCE WAS PRESSED. THE PUMP STARTED APPROPRIATELY DURING BURN IN, BUT WHEN IT WAS TIME FOR IT TO BE TURNED OFF, THE PUMP WOULD NOT TURN OFF. WHEN THE PUMP STOP BUTTON WAS PRESSED IT DISPLAYED "PUMP STOPPING", BUT DID NOT COUNT DOWN. APPROXIMATELY 6-7 ATTEMPTS TO STOP THE PUMP WERE MADE AND THE SAME THING HAPPENED. NEXT TO THE "PUMP STOPPING" MESSAGE THE VC WOULD INTERMITTENTLY SEE THE NUMBER 82 OR 81 DISPLAY. EVENTUALLY, THE VC TRIED TO TURN THE SPEED UP TO SEE IF OTHER COMMANDS WOULD RESPOND AND SHE WAS ABLE TO TURN THE SPEED UP WITHOUT ANY ISSUE. WHEN THE VC TRIED TO STOP THE PUMP AFTER CHANGING THE SPEED, IT STOPPED APPROPRIATELY. A SECOND STERILE SYSTEM CONTROLLER WAS OBTAINED AND OPERATED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270111 HEARTMATE II SYSTEM CONTROLLER DSQ: LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103696 125776

    Patients

    Seq Age Sex Outcome Treatment
    1 Other