BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4151062 · Received October 8, 2014

    Report

    Report Number
    3007042319-2014-01040
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    July 23, 2014
    Report Date
    September 8, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1813-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    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 WITHIN THIRTY (30) DAYS OF COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE HEARTWARE VAD IS USED FOR TREATMENT NOT DIAGNOSIS. (B)(4) WAS RETURNED FOR EVALUATION. 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 CONTROLLER REVEALED NO SIGNS OF PHYSICAL DAMAGE OR CONTAMINATION. ANALYSIS OF THE DEVICE REVEALED THAT THE DEVICE FAILED TO MEET SPECIFICATIONS. THE CONTROLLER FAILED FUNCTIONAL TESTING AS SYSTEM TESTING RESULTED IN CONTROLLER FAULT ALARMS. THE CONFIRMED MALFUNCTION IS RELATED TO THE REPORTED EVENT. THE REPORTED EVENT WAS CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES, WHICH REVEALED A "CONTROLLER FAULT" ALARM ON THE DATE OF THE REPORTED EVENT. CONTROLLER FAULTS OF THIS TYPE ARE CAUSED BY A LEAKY DIODE AND ARE HIGHLY INTERMITTENT. HEARTWARE HAS OPENED AN INTERNAL INVESTIGATION TO EVALUATE THESE TYPES OF ISSUES. THERE ARE NO KNOWN CLINICAL FACTORS THAT COULD HAVE CONTRIBUTED TO THIS EVENT. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT IS A FAULTY DIODE. 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.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS PART OF A FIELD SAFETY NOTIFICATION AND NOT A RECALL. THE CONTROLLER PASSED EXTERNAL VISUAL INSPECTION. SYSTEM RUNNING TEST EXHIBITED [?]CONTROLLER FAULTS' AND 'POWER DISCONNECT' ALARMS. LOG FILES ALSO REVEAL MULTIPLE CONTROLLER FAULTS ON THE REPORTED EVENT DATE. THIS DEVICE IS USED FOR TREATMENT AND NOT DIAGNOSIS. 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, INCLUDING TRANSPORTATION.

    Description of Event or Problem · 1

    APPROXIMATELY TWO YEARS AND SIX WEEKS POST HEARTWARE LVAD IMPLANTATION, IT WAS REPORTED THAT THE PATIENT PERFORMED AN ELECTIVE CONTROLLER EXCHANGE AFTER EXPERIENCING SEVERAL "CONTROLLER FAULT" ALARMS. 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
    633543 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

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