BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4076493 · Received August 19, 2014

    Report

    Report Number
    2916596-2014-01490
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 21, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP IS STILL IN USE SUPPORTING THE PT; HOWEVER, THE REPLACED PORTION OF THE PERCUTANEOUS LEAD WAS RETURNED TO THE MFR FOR EVAL. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE HOSPITAL RECEIVED A CALL FROM THE PT'S WIFE STATING THAT THE PT HAD A DRIVELINE DISCONNECT ALARM WHILE ON THE POWER MODULE. THE PT ALSO EXPERIENCED FLUTTERING IN HIS CHEST. THE PT'S SYSTEM CONTROLLER WAS EXCHANGED WITH HIS BACKUP SYSTEM CONTROLLER; HOWEVER, THE SAME EVENT OCCURRED WHILE ON BATTERY POWER. THE PT STATED THIS IT WAS A FRESH SET OF BATTERIES; HOWEVER, WHEN HE ARRIVED IN THE ER THE BATTERIES WERE COMPLETELY DEAD, WITH ONE OF THEM NEEDING TO BE CALIBRATED. WHEN THE PT ARRIVED IN THE ED HE WAS CONNECTED TO THE POWER MODULE AND IT ALARMED ONCE WITH MOVEMENT. HE WAS THEN SWITCHED TO BATTERY POWER AND THE ALARM WAS RESOLVED. THE PT HAD REPORTEDLY EXPERIENCED RED HEART AND DRIVELINE. DISCONNECT ALARMS. THE PRIMARY SYSTEM CONTROLLER WAS INTERROGATED AND EVERY TIME IT WAS CONNECTED TO THE POWER MODULE THE YELLOW WRENCH APPEARED. APPROXIMATELY 7 DAYS LATER A PORTION OF THE DISTAL END OF THE PERCUTANEOUS LEAD WAS REPLACED BY THE MFR'S TECHNICAL SERVICE REPRESENTATIVE, DUE TO RED HEART ALARMS, LOW SPEED AND PUMP STOP EVENTS THAT OCCURRED WHEN THE PT WAS CONNECTED TO THE PT CABLE. A CLAMSHELL REPAIR WAS ALSO PERFORMED PER REQUEST FROM THE HOSPITAL STAFF AS A PREVENTIVE PRECAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496823 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 122476

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other