BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM

    MDR report key: 3912698 · Received July 3, 2014

    Report

    Report Number
    3007042319-2014-00695
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    November 1, 2013
    Report Date
    February 17, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY EVALUATION AND TESTING REVEALED THAT THE RETURNED BATTERY CONTAINED A FAULTY CELL. THIS FINDING WAS RE-ASSESSED PER OUR SOP REQUIREMENTS, AND DETERMINED TO BE REPORTABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF COMPLETION OF THE INVESTIGATION. THIS EVENT RELATES TO THE FSCA Z-1607-2014 ISSUED BY HEARTWARE, INC. FOR THIS MATTER. THIS IS ONE OF FOUR REPORTS (3007042319-2014-00177, 3007042319-2014-00693, 3007042319-2014-00694, AND 3007042319-2014-00695) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT. EVALUATION IN PROGRESS.

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. SITE REPORTED THAT A PATIENT WAS EXPERIENCING POWER SWITCHING AND SUBSEQUENTLY RESULTED IN A VAD STOP. THE PATIENT LOST CONSCIOUSNESS AS A RESULT OF THE REPORTED EVENT BUT WAS STABLE AFTER THE PUMP OPERATION RESUMED. SIX (6) BATTERIES WERE EXCHANGED BY THE FACILITY AND RETURNED TO THE MANUFACTURER. THREE (3) OF THE SIX (6) BATTERIES DID NOT REVEAL ANY FAILURES. THREE (3) OF THE SIX (6) BATTERIES REVEALED SIGNS OF BATTERY DEPLETION. 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. 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. PER THE INSTRUCTIONS FOR USE (IFU): PATIENTS ARE INSTRUCTED TO ALWAYS KEEP A SPARE SET OF FULLY CHARGED BATTERIES AVAILABLE AT ALL TIMES, BEYOND THE TWO (2) POWER SOURCES THAT ARE CURRENTLY CONNECTED TO THE CONTROLLER. THE INSTRUCTIONS FOR USE AND PATIENT MANUAL INCLUDE A REFERENCE GUIDE FOR ALARMS INCLUDING POTENTIAL CAUSES AND ACTIONS TO TAKE. ADDITIONALLY THERE IS A WARNING TO KEEP SPARE, FULLY CHARGED BATTERIES AND BACK UP CONTROLLER AVAILABLE AT ALL TIME. THE STEPS FOR EXCHANGE OF DEVICES ARE ALSO OUTLINED. 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. THIS IS ONE OF SIX REPORTS 3007042319-2014-00693, 3007042319-2014-00694, 3007042319-2014-00695, 3007042319-2014-00177, 3007042319-2015-03449 AND 3007042319-2015-03450 SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE BATTERY WAS RETURNED; VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE BATTERY IN RELATION TO THE REPORTED EVENT. THOROUGH EXTERNAL VISUAL INSPECTION OF THE BATTERY REVEALED NO SIGNS OF PHYSICAL DAMAGE OR CONTAMINATION. FUNCTIONAL TESTING REVEALED THAT THE RETURNED BATTERY CONTAINED A FAULTY CELL PAIR. AN INTERNAL INVESTIGATION (CAPA) HAS BEEN OPENED TO ADDRESS THE ISSUE. THIS IS ONE OF FOUR REPORTS (3007042319-2014-00177, -2014-00693, -2014-00694 AND -2014-00695) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Description of Event or Problem · 1

    THIS EVENT INVOLVED A PATIENT WHO EXPERIENCED PROBLEMS WITH HIS BATTERIES THIRTY-NINE (39) MONTHS POST HEARTWARE LVAD IMPLANTATION. THE REPORT RECEIVED INDICATED THAT WHEN THE PATIENT WAS GOING TO THE BATHROOM AT NIGHT, HE EXPERIENCED A CHANGE OF POWER SOURCE IN THE CONTROLLER EARLIER THAN EXPECTED AND A PUMP STOP. HE LOST CONSCIOUSNESS FOR A SHORT MOMENT. WHEN HE WOKE UP, THE PUMP WAS RUNNING NORMALLY. PRELIMINARY LOG FILES REVIEW SHOWED A PUMP STOP. THE BATTERIES WERE REMOVED FROM THE PATIENT AND A NEW SET WAS SUPPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389392 HEARTWARE VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, BATTERY DSQ HEARTWARE, INC

    Patients

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