BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4200799 · Received October 24, 2014

    Report

    Report Number
    3007042319-2014-01145
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    July 31, 2014
    Report Date
    September 24, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1607-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE HAS INDICATED THAT THE PUMP REMAINS IMPLANTED. A CONTROLLER AC ADAPTER AND TWO BATTERIES WERE EXCHANGED WITHOUT INCIDENT AND THERE WAS NO REPORTED PATIENT INJURY; THE DEVICES WERE RETURNED TO HEARTWARE FOR EXAMINATION. THE CAC ADAPTER AND BATTERIES PASSED VISUAL AND FUNCTIONAL EXAMINATION; TESTING REVEALED THAT THE DEVICES PERFORMED AS EXPECTED AND THAT THE REPORTED BURNING SCENT FROM THE CAC ADAPTER COULD NOT BE DUPLICATED AT THE BENCH LEVEL. HOWEVER, A REVIEW OF THE CONTROLLER LOG FILES CONFIRMED THE REPORTED POWER SWITCHING EVENT. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; INAPPROPRIATE POWER SWITCHING EVENTS ARE MOST OFTEN ATTRIBUTED TO CORRUPT COMMUNICATION BETWEEN THE BATTERY AND CONTROLLER. AN INTERNAL INVESTIGATION (CAPA) HAS BEEN OPENED TO ADDRESS THE ISSUE.

    Additional Manufacturer Narrative · 1

    THE HVAD REMAINS IMPLANTED IN THE PATIENT, THEREFORE IT WILL NOT BE RETURNED. HOWEVER, THE BATTERIES AND CAC ADAPTER ((B)(4)) HAVE BEEN RECEIVED AND ARE AWAITING FURTHER ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. PRODUCT REMAINS IMPLANTED.

    Description of Event or Problem · 1

    APPROXIMATELY TWO YEARS AND SEVEN MONTHS POST HVAD IMPLANTATION, IT WAS REPORTED THAT THE PATIENT EXPERIENCED POWER SWITCHING FROM ONE PORT TO THE OTHER EARLIER THAN EXPECTED. IT WAS ALSO REPORTED THAT THE PATIENT NOTICED A BURNING SMELL FROM THE AC ADAPTER. BOTH THE BATTERIES AND THE CAC ADAPTER WERE REPLACED AND RETURNED TO HEARTWARE FOR EVALUATION. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THIS EVENT. IT IS NOT KNOWN WHETHER THE CAC ADAPTER IS PART OF THE SAME EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE SITE AND FIELD REPRESENTATIVES TO CLARIFY THE EVENT FURTHER. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679736 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) _BATTERY| (B)(4) _CAC ADAPTER| (B)(4) _BATTERY