BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4170513 · Received October 14, 2014

    Report

    Report Number
    3007042319-2014-01092
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    May 12, 2014
    Report Date
    September 18, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND EVALUATION STILL ONGOING. PRELIMINARY EVALUATION AND TESTING OF THE RETURNED BATTERY (B)(4) REVEALED AN INTERNAL FAULTY CELL. THIS FINDING WAS RE-ASSESSED PER OUR SOP REQUIREMENTS, AND DETERMINED TO BE REPORTABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE SITE HAS INDICATED THAT THE PUMP REMAINS IMPLANTED. THE BATTERY WAS RETURNED; VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. THOROUGH EXTERNAL VISUAL INSPECTION OF THE BATTERY REVEALED NO SIGNS OF PHYSICAL DAMAGE OR CONTAMINATION. REVIEW OF CONFORMANCE MATERIAL RECORD CONFIRMED THAT THE BATTERY MET ALL REQUIREMENTS FOR RELEASE. FUNCTIONAL TESTING REVEALED THAT THE RETURNED BATTERY CONTAINED A FAULTY CELL PAIR WHICH LIKELY CONTRIBUTED TO THE REPORTED EVENT. AN INTERNAL INVESTIGATION (CAPA) HAS BEEN OPENED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    THIS EVENT INVOLVED A PATIENT 5 MONTH POST HEARTWARE LVAD IMPLANTATION THAT EXPERIENCED INADEQUATE POWER ISSUES WITH A SINGLE BATTERY. THE PATIENT STATED THAT THE BATTERY WAS DROPPING THE CHARGE FROM 4 BAR TO 1 BAR QUICKLY. THE BATTERY WAS REMOVED FROM THE PATIENT AND A NEW BATTERY WAS SUPPLIED. NO HARM OR INJURY TO THE PATIENT WAS REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651094 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

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