BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2503071 · Received March 21, 2012

    Report

    Report Number
    2916596-2012-00254
    Event Type
    Injury
    Date Received
    March 21, 2012
    Date of Event
    February 21, 2012
    Report Date
    February 21, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. DURING THE ANALYSIS, THE SYSTEM CONTROLLER COULD NOT OPERATE A PUMP IN ITS RECEIVED CONDITION. FURTHER INVESTIGATION REVEALED THAT TWO FUSES WERE OPEN ON THE INNER CONTROLLER PRINTED CIRCUIT BOARD (PCB). THESE FUSES WERE REPLACED AND THE CONTROLLER WAS TESTED AGAIN AND FUNCTIONED AS EXPECTED. THE DAMAGED FUSES SUGGEST THAT THE DRIVELINE IS COMPROMISED, WHICH IS CONSISTENT WITH THE REPORTED EVENT AND SUSPECTED COMPROMISED PERCUTANEOUS LEAD (REFERENCE MANUFACTURER REPORT NUMBER 2916596-2012-00250). PER DESIGN, IN THE EVENT THAT THE DRIVELINE IS COMPROMISED THE FUSES CAN BE SUSCEPTIBLE TO DAMAGE. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET ALL APPLICABLE SPECIFICATIONS UPON PRODUCT RELEASE. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    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 PT PULLED THE DRIVELINE ON A DOOR AND RECEIVED A CONTINUOUS ALARM WITH NO LIGHTS DISPLAYED ON THE SYSTEM CONTROLLER (REFERENCE MANUFACTURER REPORT NUMBER 2916596-2012-00250). THE SYSTEM CONTROLLER WAS EXCHANGED AND THE ALARM WAS RESOLVED. DURING TRANSIT TO THE HOSPITAL, THE PATIENT RECEIVED TWO RED HEART ALARMS THAT LASTED FOR A FEW SECONDS AND RESOLVED ON THEIR OWN. THE LOG FILE WAS REVIEWED AND TWO LOW SPEED OPERATIONS WERE NOTED, WITH THE SPEED DECREASING TO 5,400 AND 7,000 RPMS. A CT SCAN WAS PERFORMED THE FOLLOWING DAY AND SHOWED MILD THINNING OF THE MEDICAL DRIVELINE APPROXIMATELY 5.5 CM FROM THE CONNECTION TO THE SYSTEM CONTROLLER. THE PT WAS ADMITTED INTO THE HOSPITAL AND STABILIZED FOR THE NEXT FEW DAYS AND THE PT WAS ACTIVE AND MOVING AROUND. THE EXTERNAL PERCUTANEOUS LEAD WAS MANIPULATED WHERE DAMAGE WAS SUSPECTED; HOWEVER, THE ALARMS COULD NOT BE REPRODUCED. AS A PRECAUTION, THE SUSPECTED SECTION OF THE PERCUTANEOUS LEAD WAS SPLINTED AND STABILIZED TO REDUCE FURTHER DAMAGE. TEN DAYS LATER THE LVAD WAS EXCHANGED WITH A NEW LVAD. THE PT REMAINS ONGOING WITH THE NEW LVAD. THE LVAD AND SYSTEM CONTROLLER WERE RETURNED FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention