BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4180612 · Received October 17, 2014

    Report

    Report Number
    3007042319-2014-01065
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 18, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT THIS PATIENT COULD NOT SECURELY CONNECT THE CONTROLLER TO THE POWER SOURCE AND IT WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THIS EVENT. THE CONTROLLER, (B)(4), WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. ANALYSIS OF THE RETURNED CONTROLLER REVEALED A BROKEN PIN ON THE POWER SOURCE TWO (2) CONNECTOR AND WAS UNABLE TO TRANSFER ELECTRICAL SIGNAL FROM THE BATTERY OR AC POWER SOURCE. THE ROOT CAUSE FOR THE 'POOR MECHANICAL CONNECTION' EVENT WAS FOUND TO BE A DAMAGED PIN ON THE POWER SOURCE CONNECTOR, MOST LIKELY A RESULT OF IMPROPER HANDLING, MATERIAL DURABILITY AND ASSEMBLY INTERFERENCES. THE MANUFACTURER HAS AN OPEN INTERNAL INVESTIGATION TO EVALUATE THESE TYPES OF ISSUES. Z-1698-2015: A FIELD SAFETY NOTICE (FSCA APR2015A) WAS ISSUED TO CLINICIANS TO BE DELIVERED TO PATIENTS CURRENTLY ON DEVICE. IT PROVIDED AWARENESS, WARNINGS, AND SAFETY MITIGATIONS REGARDING WORN ALIGNMENT GUIDES RESULTING IN BENT PINS. THE FSCA INSTRUCTED PATIENTS TO INSPECT THE POWER SUPPLY PORTS ON THEIR CONTROLLERS FOR POTENTIAL WEAR OR DAMAGE TO THE ALIGNMENT GUIDES OR CONNECTION PINS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. PER THE INSTRUCTIONS FOR USE (IFU): PATIENTS ARE INSTRUCTED TO ALWAYS KEEP A BACK-UP CONTROLLER AVAILABLE AT ALL TIMES, BEYOND THE PRIMARY CONTROLLER THAT IS CURRENTLY IN USE. PATIENTS ARE INSTRUCTED TO CONTACT THE TREATING FACILITY IF THEY RECEIVE ANY OF A LIST OF CERTAIN ALARMS. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. HEARTWARE IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER FLA-14-14, DATED JUNE 2, 2014, AND PURSUANT TO THE PROVISIONS OF 21 CFR PART 803. (B)(4).

    Additional Manufacturer Narrative · 1

    THE HVAD REMAINS IMPLANTED IN THE PATIENT, THEREFORE IT WILL NOT BE RETURNED. HOWEVER, THE CONTROLLER ((B)(4)) IS AVAILABLE FOR EVALUATION, BUT HAS NOT BEEN RECEIVED BY THE MANUFACTURER. ADDITIONAL INFORMATION WILL BE SUBMITTED WITH-IN THIRTY (30) DAYS OF COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    APPROXIMATELY TWO MONTHS AND ONE WEEK POST HEARTWARE LVAD IMPLANTATION, IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ELECTIVE CONTROLLER EXCHANGE DUE TO A BENT PIN IN A CONTROLLER POWER PORT. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THIS EVENT. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662798 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR