BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM- BATTERY

    MDR report key: 7454655 · Received April 24, 2018

    Report

    Report Number
    3007042319-2018-01571
    Event Type
    Malfunction
    Date Received
    April 24, 2018
    Date of Event
    March 28, 2018
    Report Date
    August 24, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000376
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE BATTERY WAS RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. THE REPORTED EVENT COULD NOT BE CONFIRMED DURING TESTING. FAILURE ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE DEVICE PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. THE BATTERY WAS ABLE TO ADEQUATELY PROVIDE POWER TO A TEST CONTROLLER. IN ADDITION, THE BATTERY WAS CHARGING WHEN CONNECTED TO A BATTERY CHARGER. A REVIEW OF THE BATTERY'S INTERNAL LOG REVEALED THAT A CELL PAIR, AT ONE POINT IN TIME, PASSED THE VOLTAGE THRESHOLD. WHEN THIS OCCURS, THE BATTERY WILL NOT CHARGE UNTIL THE VOLTAGE DECREASES BELOW THE THRESHOLD. HOWEVER, THE BATTERY WAS RECEIVED WITH NO FLAGS ENABLED. IF THE BATTERY REMAINS CONNECTED TO THE BATTERY CHARGER WITH A CELL-OVER-VOLTAGE FLAG, THE BATTERY CHARGER STATUS INDICATOR WILL FLASH RED AFTER 8 HOURS DUE TO A CHARGE TIME-OUT. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. BASED ON THE AVAILABLE INFORMATION, A POSSIBLE ROOT CAUSE OF REPORTED EVENT CAN BE ATTRIBUTED TO AN OVERVOLTAGE FAULT DETECTED BY THE ANALOG FRONT END (AFE) INTEGRATED CIRCUIT. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION AND DESTINATION THERAPY 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY WAS NOT CHARGING, DISPLAYED A FLASHING RED INDICATOR LIGHT ON THE BATTERY CHARGER, AND WAS NOT PROVIDING POWER TO THE CONTROLLER. THE BATTERY WILL BE EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297305 HEARTWARE VENTRICULAR ASSIST SYSTEM- BATTERY VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1650 00888707000376

    Patients

    Seq Age Sex Outcome Treatment
    1 98 YR MCS UNKNOWN VAD