BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 2983051 · Received February 28, 2013

    Report

    Report Number
    3007042319-2013-00018
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 29, 2013
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT UNIT WAS RETURNED TO HEARTWARE FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE DEVICE MET ALL QUALITY REQUIREMENTS FOR RELEASE. REVIEW OF THE CONTROLLER LOG FILES REVEALED AT LEAST 4 PUMP STOPS FOLLOWED BY MOTOR STARTS BETWEEN (B)(6) 2013. THE MOTOR STARTS WERE WITHIN LESS THAN 30 SECONDS OF THE PUMP STOP EVENT. THE LOGS CONFIRMED THAT THE PUMP STOP EVENTS WERE RELATED TO DISCONNECTION OF THE PUMP DRIVELINE FROM THE CONTROLLER. THE RETURNED CONTROLLER PASSED ALL VISUAL AND FUNCTIONAL TESTING WITH NO EVIDENCE OF FAULTS OR ALARMS. ADDITIONAL TESTING CONFIRMED THAT A TEST BED PUMP DRIVELINE CONNECTOR COULD BE SUCCESSFULLY MATED AND LOCKED INTO THE RETURNED COMPLAINT CONTROLLER'S DRIVELINE CONNECTOR PORT. FURTHERMORE, THE CONNECTION COULD NOT BE BROKEN WITHOUT PROPERLY UNLOCKING THE DRIVELINE FROM THE CONTROLLER. THE LOG FILES CONFIRM SEVERAL PUMPS STOPS THAT CORRELATED TO THE REPORTED EVENT; HOWEVER, THE REPORTED COMPLAINT COULD NOT BE REPLICATED DURING TESTING OF THE RETURNED COMPLAINT UNIT. THE CAUSE OF THE PUMP STOPS IS RELATED TO DISCONNECTION OF THE PUMP DRIVELINE FROM THE CONTROLLER. WHILE THE ROOT CAUSE OF THE DRIVELINE DISCONNECT CANNOT BE CONCLUSIVELY DETERMINED, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO A DEVICE DEFECT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND IS AWAITING FURTHER ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THIS EVENT INVOLVED A PATIENT WHO EXPERIENCED A LOOSE CONNECTION OF THE DRIVELINE CONNECTOR PORT OF THE CONTROLLER APPROXIMATELY SIX WEEKS POST HEARTWARE LVAD IMPLANTATION. THE HOSPITAL REPORTED THAT THE PATIENT HAD EXPERIENCED LOOSE DRIVELINE CONNECTIONS ON A COUPLE OF OCCASIONS WITH ASSOCIATED DISCONNECT AND VAD STOP ALARMS. AT THE TIME OF THE EVENT, THE PATIENT REPORTED THAT HE/SHE WAS MOVING FROM BED TO CHAIR. IN ADDITION, THEIR CARRYING CASE WAS BEING CARRIED AND THAT THE DRIVELINE DID NOT CATCH OR GET PULLED ON ANYTHING DURING THIS PROCESS. THEY FURTHER REPORTED THAT THE DRIVELINE CONNECTOR COULD BE EASILY DISCONNECTED FROM THE CONTROLLER CONNECTOR WITH LITTLE RESISTANCE. THE CONTROLLER WAS EXCHANGED WITH NO REPORTED PATIENT INJURY. THERE WAS NO INDICATION OF ANY DAMAGE OR DEFECT OF THE PUMP DRIVELINE CONNECTOR. THEY CONFIRMED THAT THE DRIVELINE IS NOW WELL CONNECTED TO THE NEW CONTROLLER. THE SITE HAS INDICATED THAT IT WILL BE RETURNING THE CONTROLLER TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85535 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, CONTROLLER DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1