BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3884941 · Received June 19, 2014

    Report

    Report Number
    3007042319-2014-00640
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEARTWARE VAD IS USED FOR TREATMENT NOT DIAGNOSIS. THREE BATTERIES AND ONE CONTROLLER WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. THOROUGH EXTERNAL VISUAL INSPECTION OF THE DEVICES REVEALED NO SIGNS OF PHYSICAL DAMAGE OR CONTAMINATION. ANALYSIS OF THE DEVICES REVEALED THAT THE BATTERIES AND CONTROLLER MET SPECIFICATIONS; THE BATTERIES AND CONTROLLER PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. THE REPORTED EVENT WAS CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES, WHICH REVEALED CRITICAL BATTERY ALARMS. ADDITIONALLY, LOG FILE ANALYSES REVEALED A POWER DISCONNECT ALARM THAT WAS MOST LIKELY CAUSED BY A COMMUNICATION ERROR AND NOT A TRUE DISCONNECTION OF THE ASSOCIATED POWER SOURCE. THE PATIENT ALSO EXPERIENCED A CRITICAL BATTERY ALARM ON POWER PORT 2 ((B)(4)) WHEREIN THE BATTERY CAPACITY WENT FROM 70 % TO 0%. GIVEN THAT IT'S HIGHLY UNLIKELY THAT THE BATTERY WOULD LOSE ALL OF ITS CHARGE IN A SHORT AMOUNT OF TIME, THE MOST LIKELY ROOT CAUSE OF THE CRITICAL BATTERY ALARM IS A COMMUNICATION ERROR. THE LOGS REVEALED A CONTROLLER POWER UP AND MOTOR START EVENT SHORTLY AFTER EXPERIENCING THE CRITICAL BATTERY ALARM. IT WAS NOTED IN THE EVENT DETAILS THAT THE PATIENT ATTEMPTED TO RESOLVE THE ISSUE BY RECONNECTING BOTH POWER SOURCES, WHICH WOULD HAVE LED TO A LOSS OF POWER AND A SUBSEQUENT CONTROLLER POWER UP AND MOTOR START EVENT ONCE POWER WAS RESUMED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A "PUMP STOP"; HOWEVER, LOG FILE ANALYSIS INDICATES THAT THE PATIENT POSSIBLY MISINTERPRETED A CRITICAL BATTERY ALARM FOR A VAD STOP ALARM. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; EVENTS WITH CRITICAL BATTERY ALARMS OF SCREENED BATTERIES ARE MOST OFTEN ATTRIBUTED TO A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND BATTERY. THE MOST LIKELY ROOT CAUSE IS A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND BATTERIES. HEARTWARE HAS OPENED AN INTERNAL INVESTIGATION TO EVALUATE THESE TYPES OF ISSUES. THERE ARE NO KNOWN CLINICAL OR USER RELATED FACTORS THAT COULD HAVE CONTRIBUTED TO THIS EVENT. THIS DEVICE IS USED FOR TREATMENT 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. 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. THIS IS ONE OF FIVE REPORTS (3007042319-2014-00640 AND 3007042319-2015-01417, 01418, 01419, 01420) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT. 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

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. PRODUCT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    APPROXIMATELY ONE YEAR AND ONE WEEK AFTER THE IMPLANTATION, IT WAS REPORTED THAT THE PATIENT HAD A "CRITICAL BATTERY" ALARM FOLLOWED BY A LOSS OF POWER. THE CONTROLLER WAS REMOVED FROM THE PATIENT AND A NEW CONTROLLER WAS SUPPLIED. NO HARM OR INJURY TO THE PATIENT WAS REPORTED AS A RESULT OF THIS INCIDENT. A PRELIMINARY REVIEW OF THE CONTROLLER LOG FILES REVEALED A LOSS OF POWER ON THE REPORTED EVENT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359941 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, CONTROLLER DSQ HEARTWARE, INC

    Patients

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