BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM

    MDR report key: 6243417 · Received January 11, 2017

    Report

    Report Number
    3007042319-2017-00093
    Event Type
    Malfunction
    Date Received
    January 11, 2017
    Date of Event
    May 30, 2016
    Report Date
    June 2, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION TO FINAL CONCLUSION: IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING POWER SWITCHING EVENTS. THE BATTERY WAS RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE DEVICE PASSED VISUAL EXAMINATION BUT FAILED INITIAL FUNCTIONAL TESTING. TEST EQUIPMENT WAS UNABLE TO READ THE BATTERY STATUS. INTERNAL INSPECTION OF THE BATTERY REVEALED THAT THE CELL VOLTAGES WERE UNDER THE NOMINAL RANGE. AFTER THE BATTERY WAS FULLY CHARGED, IT WAS ABLE TO COMMUNICATE WITH TEST EQUIPMENT AND PERFORMED AS EXPECTED. ANALYSIS OF THE DATA LOG FILES REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERY. HEARTWARE HAS OPENED AN INTERNAL INVESTIGATION TO ADDRESS MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4) WAS NOT RETURNED FOR EVALUATION. ANALYSIS OF THE DEVICE COULD NOT BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE'S INCOMING INSPECTION RECORDS INDICATED THAT THE UNIT MET THE INTERNAL REQUIREMENTS PRIOR TO ITS QUALITY ASSURANCE RELEASE PROCESS. REVIEW OF INVENTORY CONTROL RECORDS (QAD) CONFIRM THAT THE UNIT WAS NOT RETURNED FOR ANALYSIS. THE REPORTED EVENT (BATTERY SWITCHING ON/OFF) WAS VERIFIED. THE CONTROLLER SERIAL NUMBER (B)(4), WHICH PROVIDED THE LOGS FOR THIS ANALYSIS, LOGGED ONE VAD STOPPED ALARM ON (B)(6) 2016 AT 11:33:43. LOGS INDICATE THAT THIS WAS DUE TO A PHYSICAL DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLER. THE SMR SOFTWARE THAT IS INSTALLED IN THE CONTROLLER HAS A FEATURE THAT IDENTIFIES IF A POWER SWITCHING EVENT OCCURRED DUE TO A COMMUNICATION ERROR OR MOMENTARY DISCONNECTION. REVIEW OF THE LOG FILES REVEALED A FEW OCCURRENCES OF POWER SWITCHING EVENTS DUE TO MOMENTARY DISCONNECTS. THE FOLLOWING BATTERIES WERE INVOLVED DURING THE POWER SWITCHING EVENTS DUE TO MOMENTARY BATTERY DISCONNECTIONS: (B)(4). THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO A MOMENTARY DISCONNECTION BETWEEN THE CONTROLLER AND THE BATTERIES. 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. THE INSTRUCTIONS FOR USE AND PATIENT MANUAL OUTLINE THE STEPS FOR HANDLING AND PROPERLY CONNECTING POWER SOURCES, INCLUDING ENSURING PROPER ALIGNMENT, AS WELL AS INSTRUCTIONS NOT TO TWIST OR FORCE CONNECTIONS TOGETHER IN ORDER TO PREVENT DAMAGES. ADDITIONALLY, A REFERENCE GUIDE FOR BOTH VISUAL AND TONE ALARMS INCLUDING POTENTIAL CAUSES AND ACTIONS TO TAKE AND THERE IS A WARNING TO KEEP SPARE, FULLY CHARGED BATTERIES AND BACK UP CONTROLLER AVAILABLE AT ALL TIMES. IT ALSO PROVIDES INFORMATION ABOUT PROPER CARE OF THE SYSTEM AND WHAT TO DO IN CASE OF AN EMERGENCY. ALWAYS WAIT UNTIL THE "READY" TURNS ON TO DISCONNECT THE BATTERY FROM THE BATTERY CHARGER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A BATTERY THAT WOULD SWITCH ON AND OFF. ON ITS OWN THE BATTERY WAS REMOVED FROM SERVICE AND EXCHANGED WITH NO REPORTED CONSEQUENCES OR IMPACT TO PATIENT. THE BATTERY CAPACITY AT THE TIME OF THE REPORTED EVENT WAS GREATER THAN 25%. THE SWITCHING COULD NOT BE REPRODUCED BY MANIPULATING CONNECTIONS. REVIEW OF THE LOG FILES REVEALED A FEW OCCURRENCES OF POWER SWITCHING EVENTS DUE TO MOMENTARY DISCONNECTS, THUS CONFIRMING THE REPORTED EVENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25518 HEARTWARE VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, BATTERY DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR