BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM

    MDR report key: 3920136 · Received July 8, 2014

    Report

    Report Number
    3007042319-2014-00708
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 8, 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
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT THE PATIENT'S CONTROLLER ALARMED AND DISPLAYED A BLANK SCREEN; BOTH BATTERIES WERE CONNECTED AT THE TIME OF THE ALARM. THE PATIENT'S WIFE PERFORMED A CONTROLLER EXCHANGE AT HOME. THE SAME BATTERIES WERE CONNECTED AFTER THE CONTROLLER EXCHANGE, HOWEVER THE CONTROLLER DID NOT START UNTIL TWO DIFFERENT BATTERIES WERE CONNECTED. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THIS EVENT. TWO BATTERIES AND A CONTROLLER WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE CONTROLLER IN RELATION TO THE REPORTED EVENT. THOROUGH EXTERNAL VISUAL INSPECTION OF THE CONTROLLER REVEALED NO SIGNS OF PHYSICAL DAMAGE OR CONTAMINATION. THE SYSTEM RUNNING TEST ENCOUNTERED NO ANOMALIES WITH THE OPERATION OF THE CONTROLLER; THE DEVICE PERFORMED PER SPECIFICATION AT THE BENCH. THE REPORTED 'POWER DISCONNECT' WAS CONFIRMED VIA LOG FILE ANALYSIS WHICH CONFIRMED A 'VAD STOP' ON THE DATE OF THE REPORTED EVENT; THE LOG FILE REVIEW COULD NOT ASSOCIATE ANY GIVEN BATTERY WITH THE REPORTED EVENT. THE ROOT CAUSE FOR THE REPORTED "POWER DISCONNECT ALARM" COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER IT CAN BE ATTRIBUTED TO LOSS OF POWER FROM THE MENTIONED BATTERIES. AS A RESULT, THE DEVICES ARE NOT AVAILABLE FOR ANALYSIS, SUBSEQUENTLY THE ROOT CAUSE FOR THE "NO POWER" EVENTS CANNOT BE DETERMINED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE RESULTS OF THE PREVIOUS MANUFACTURER'S INTERNAL INVESTIGATION, FIELD ACTIONS AND CHANGES TO THE BATTERY INTERNAL CELL SUPPLIER, NO ADDITIONAL INVESTIGATION OF THIS EVENT IS REQUIRED AT THIS TIME. THE MOST LIKELY CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO FAULTY INTERNAL CELLS WITHIN THE BATTERY PACK. (B)(4). FIELD SAFETY NOTICE (FSCA APR2014) WAS ISSUED TO PROVIDE PATIENTS AND HEALTHCARE PROVIDERS WITH INFORMATION TO RECOGNIZE BATTERIES WITH LESS THAN TWO HOURS OF RUN TIME, AS WELL AS REEMPHASIZE INSTRUCTION ON ACTIONS TO TAKE WHEN BATTERY ALARMS OCCUR AND REINFORCE PROPER POWER MANAGEMENT FIELD SAFETY NOTICE WAS THEN EXPANDED (FSCA APR2014.1) IN ORDER TO REMOVE BATTERIES FROM THE FIELD THAT WERE RELEASED PRIOR TO THE IMPLEMENTATION OF ENHANCED BATTERY SCREENING PROCESS TO ADDRESS AND PREVENT BATTERY FAILURES. 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. THE INSTRUCTIONS FOR USE (IFU), PATIENT MANUAL, AND TRAINING MATERIAL PROVIDE CLEAR INSTRUCTIONS TO THE USER ON PROPER USAGE AND CARE OF POWER SOURCES. THE IFU PROVIDES INSTRUCTION TO FURTHER EDUCATE THE PATIENT ABOUT PRODUCT SAFETY, VISUAL AND AUDIBLE ALARM MANAGEMENT, AND DEVICE MANAGEMENT; ADDITIONAL GUIDELINES INSTRUCT THE USER ON HOW TO DETECT AND REACT TO A POWER SOURCE MALFUNCTION. ADDITIONALLY THERE IS A WARNING TO KEEP SPARE, FULLY CHARGED BATTERIES AND BACK UP CONTROLLER AVAILABLE AT ALL TIME. THE STEPS FOR EXCHANGE OF BATTERIES AND CONTROLLERS ARE OUTLINED. 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. THIS IS ONE OF TWO REPORTS (3007042319-2013-00707 AND 3007042319-2013-00708) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT. EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    APPROXIMATELY ELEVEN MONTHS POST HVAD IMPLANTATION, IT WAS REPORTED THAT THE PATIENT WAS AT HOME WHEN THEIR CONTROLLER ALARMED AND DISPLAYED A BLANK SCREEN. IT WAS REPORTED THAT BOTH BATTERIES WERE CONNECTED AT THE TIME OF THE ALARM. THE PATIENT'S WIFE PERFORMED A CONTROLLER EXCHANGE AT HOME. THE SAME BATTERIES WERE CONNECTED AFTER THE CONTROLLER EXCHANGE; HOWEVER, THE CONTROLLER DID NOT SUCCESSFULLY RESTART UNTIL TWO DIFFERENT BATTERIES WERE CONNECTED. 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. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398170 HEARTWARE VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, BATTERY DSQ HEARTWARE, INC

    Patients

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