BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2831222 · Received November 6, 2012

    Report

    Report Number
    2916596-2012-01088
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 9, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO THE MANUFACTURER, AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT CALLED AND STATED THAT HE EXPERIENCED A RED HEART ALARM "WITH GREEN POWER SYMBOL ON" FOR APPROXIMATELY 9 MINUTES. THE PATIENT HAD EXCHANGED HIS BATTERIES PRIOR TO CALLING THE VAD COORDINATOR. THE PATIENT DID NOT CONNECT TO THE POWER MODULE. HE ONLY SWITCHED OVER HIS WHITE POWER LEAD. THE BLACK POWER LEAD WAS STILL CONNECTED TO BATTERY POWER. THERE WERE ONLY 2 LEDS ILLUMINATED ON EACH OF THE PATIENT'S OLD BATTERIES THAT HE HAD EXCHANGED HIS BATTERIES. THE RED HEART ALARM WAS AUDIBLE PER THE PATIENT, AND THE EMERGENCY STAFF, VAD COORDINATOR, AND FLIGHT TEAM HEARD THE ALARM. THE ALARM DID NOT RESET ITSELF UNTIL AFTER THE VAD COORDINATOR CONNECTED THE PATIENT TO THE POWER MODULE AT THE HOSPITAL. THE PATIENT'S PUMP PARAMETERS WERE NORMAL. THE VAD COORDINATOR INSPECTED THE PATIENT'S BATTERY CLIPS AND BATTERIES AND NO ISSUES WERE FOUND. THE DRIVELINE AND POWER LEADS WERE MANIPULATED AND NO ALARMS OCCURRED. VAD COORDINATOR REVIEWED THE PATIENT'S SYSTEM CONTROLLER LOG FILE AND REPORTED THAT IT CAPTURED LOW FLOW AND PUMP OFF ALARMS, AND THEN NO MORE ALARMS WERE RECORDED UNTIL SHE CONNECTED THE PATIENT TO THE POWER MODULE. X-RAYS WERE TAKEN AND WERE FOUND TO BE UNREMARKABLE. THE PATIENT WAS MADE 1A ON THE TRANSPLANT LIST AND RECEIVED A HEART TRANSPLANT A FEW DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 109061

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention