BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4200699 · Received October 24, 2014

    Report

    Report Number
    3007042319-2014-01137
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    June 23, 2014
    Report Date
    September 25, 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, THE BATTERY HAS BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION ON 07/11/2014. THE REPORTED EVENT INDICATES AN ISSUE WITH THE PERFORMANCE OF A BATTERY. THE DEVICE WAS EXCHANGED WITHOUT INCIDENT AND THERE WAS NO REPORTED PATIENT INJURY. VISUAL AND FUNCTIONAL EXAMINATION OF THE BATTERY WAS NOT CONDUCTED AS TESTING AND INVESTIGATION OF SIMILAR BATTERY PERFORMANCE ISSUES WAS PERFORMED UNDER AN INTERNAL INVESTIGATION. WHILE THE CAUSES ARE MULTIFACTORIAL, IT HAS BEEN DEMONSTRATED THAT THIS ISSUE IS MOST LIKELY RELATED TO A FAULTY INTERNAL CELL PAIR.  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 BATTERY ((B)(4)) HAS BEEN RECEIVED AND IS AWAITING FURTHER ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. PRODUCT REMAINS IMPLANTED.

    Description of Event or Problem · 1

    APPROXIMATELY THREE YEARS AND ONE MONTH POST HVAD IMPLANTATION, IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABNORMAL BATTERY BEHAVIOR THAT INCLUDED THE BATTERY NOT BEING RECOGNIZED BY THE CONTROLLER AND PREMATURE POWER SWITCHING FROM ONE PORT OF THE CONTROLLER TO THE OTHER. THE BATTERY WAS REPLACED AND RETURNED TO HEARTWARE FOR EVALUATION. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THIS EVENT; THE ISSUE WAS RESOLVED WITH THE REPLACEMENT BATTERY. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679546 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)_BATTERY