BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM

    MDR report key: 3854433 · Received June 6, 2014

    Report

    Report Number
    3007042319-2014-00581
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND IS AWAITING FURTHER ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. EVALUATION IN PROGRESS.

    Additional Manufacturer Narrative · 1

    THE BATTERY WAS RETURNED; 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 BATTERY REVEALED NO SIGNS OF PHYSICAL DAMAGE OR CONTAMINATION. THE CONTROLLER WAS NOT RETURNED FOR EVALUATION. A REVIEW OF CONTROLLER LOGS SHOWED TWO INSTANCES OF POWER UP BY CONTROLLER AND PUMP. DUE TO THE CONTROLLER NOT BEING RETURNED FOR INVESTIGATION THE CAUSE OF THIS REPORTED EVENT CANNOT BE DETERMINED. AN INTERNAL INVESTIGATION (CAPA) HAS BEEN OPENED TO ADDRESS THE ISSUE.

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT A PATIENT WAS EXPERIENCING UNPROMPTED POWER SOURCE ALTERNATION WITHIN ALL FIVE (5) BATTERIES. BATTERIES WERE EXCHANGED AND RETURNED TO MANUFACTURER FOR ANALYSIS. THERE WAS NO REPORTED PATIENT INJURY ASSOCIATED WITH THE EVENT. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. ANALYSIS OF THE DEVICE REVEALED THAT ALL BATTERIES PASSED FUNCTIONAL AND VISUAL TESTING.. 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 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 FIVE REPORTS (3007042319-2014-00581, 2015-03199, 2015-03200, 2015-03201 AND 3007042319-2015-03202) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Description of Event or Problem · 1

    APPROXIMATELY ONE YEAR AND ONE MONTH POST HVAD IMPLANTATION, THE SITE REPORTED THAT THE PATIENT EXPERIENCED POWER SOURCE CHANGE IN THE CONTROLLER EARLIER THAN EXPECTED. THE BATTERY WAS REMOVED FROM THE PATIENT AND A NEW BATTERY 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 TWO DAYS PRIOR TO THE REPORTED EVENT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332095 HEARTWARE VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, BATTERY DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 BAT041682- BATTERY| BAT044467- BATTERY| BAT041757- BATTERY| BAT040014- BATTERY