BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3043493 · Received April 9, 2013

    Report

    Report Number
    3007042319-2013-00052
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 18, 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 CONTROLLER AND BATTERIES WERE RETURNED HEARTWARE; VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. THE REPORTED EVENT FOR VAD STOP WAS CONFIRMED THROUGH LOG FILES ANALYSIS. THE LOGS SHOW THE CONTROLLER LOST POWER ONCE, TWO DAYS BEFORE THE EVENT DAY WHICH WOULD HAVE CAUSED THE HIGH-PRIORITY ALARM AND THE DISPLAY TO GO BLANK. HOWEVER, THIS COULD NOT BE DUPLICATED DURING FUNCTIONAL TESTING OF THE RETURNED DEVICES. THOROUGH EXTERNAL VISUAL INSPECTION OF THE DEVICES REVEALED NO SIGNS OF PHYSICAL DAMAGE OR LOOSE PARTS INSIDE OF THE DEVICE. THE CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED. BASED ON THE INFORMATION PROVIDED, THERE IS NO EVIDENCE TO SUGGEST A DEVICE DEFECT. NO ADDITIONAL INFORMATION WILL BE FORTHCOMING.

    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.

    Description of Event or Problem · 1

    THIS EVENT INVOLVED A PATIENT WHO EXPERIENCED A VAD STOP APPROXIMATELY SEVEN AND A HALF MONTHS POST HEARTWARE LVAD IMPLANTATION. THE PATIENT EXPERIENCED THE VAD STOP WHEN HE/SHE WAS CHANGING A DEPLETED BATTERY. THE CONTROLLER DISPLAY IS REPORTED TO HAVE GONE BLANK AND THERE WAS NO AUDIBLE ALARM. THE PATIENT FURTHER REPORTED THAT THE BATTERY THAT REMAINED IN THE CONTROLLER POWER PORT WAS FULLY CHARGED. IN ADDITION, IMMEDIATE ACTIONS BY THE PATIENT AND/OR CAREGIVER AND THE LENGTH OF TIME THE VAD WAS STOPPED WERE NOT REPORTED. THE SITE EXCHANGED THE CONTROLLER AND BATTERIES WITH NO REPORTED PATIENT INJURY. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145695 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, CONTROLLER DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 BATTERY (BAT025778)| BATTERY (BAT025779)| BATTERY (BAT025780)| BATTERY (BAT025799)