BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3191266 · Received June 26, 2013

    Report

    Report Number
    3007042319-2013-00099
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION, BUT HAS NOT BEEN RECEIVED BY THE MANUFACTURER. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. THIS IS ONE OF TWO DEVICES REPORTED FOR THIS RELATED EVENT. PLEASE REFER TO MFR. 3007042319-2013-00098.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO HEARTWARE THE CONTROLLER (B)(4) LOGS SHOWS CONTROLLER FAILED AND VAD STOP ALARMS. THE PUMP WAS STOPPED FOR AT LEAST 44 SECONDS, AND PERHAPS AS LONG AS 7-MINUTES. A PMC-RESET EVENT IS ALSO LOGGED. TESTING THE RETURNED CONTROLLER SHOWED IT RAN NORMALLY WITH NO FAULT ALARMS OR ERRORS. NO EXTERNAL VISUAL PROBLEMS WERE FOUND. THE POWER AND DRIVE CONNECTIONS ON THE RETURNED CONTROLLER WERE SECURE AND RELIABLE. CONTROLLER RAN MOTOR FOR 2-DAYS ON THE BENCH UNDER AMBIENT TEMPERATURE WITH NO PROBLEMS OBSERVED. THIS IS ONE OF FOUR REPORTS (3007042319-2013-00228, 229, 98 AND 99) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT. NO ADDITIONAL INFORMATION WILL BE FORTHCOMING.

    Description of Event or Problem · 1

    APPROXIMATELY 25 MONTHS POST HEARTWARE LVAD IMPLANTATION. THE PATIENT EXPERIENCED POOR CONNECTIONS WITH HIS CONTROLLER ((B)(4)). HE STATED THAT THE BATTERIES WERE SWITCHING FROM ONE PORT TO THE OTHER ON THE CONTROLLER FOLLOWED BY A ¿PUMP STOP¿ ALARM. THE SITE SWITCHED TO THE PATIENT¿S BACK UP CONTROLLER ((B)(4)) AND WAITED FOR APPROXIMATE 8 SECONDS FOR THE PUMP TO RESPOND; HOWEVER THE PUMP DID NOT RESTART. THE SITE PERFORMED ANOTHER EXCHANGE WITH A NEW CONTROLLER FROM HOSPITAL STOCK AND THE EVENT WAS RESOLVED. THE PATIENT DID NOT SUFFER ANY INJURIES DURING THE EVENT AND REMAINS IN STABLE CONDITIONS. THE DEVICES ARE IN ROUTE TO HEARTWARE FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291173 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, CONTROLLER DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 BATTERY ((B)(4))| BATTERY ((B)(4))| BATTERY ((B)(4))