BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM-BATTERY

    MDR report key: 7575352 · Received June 6, 2018

    Report

    Report Number
    3007042319-2018-02256
    Event Type
    Malfunction
    Date Received
    June 6, 2018
    Date of Event
    October 31, 2017
    Report Date
    August 23, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000369
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE BATTERY WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS REVEALED THAT THE UNIT PASSED VISUAL INSPECTION. FUNCTIONAL TESTING REVEALED THAT THE BATTERY WAS UNABLE TO CHARGE DUE TO A FLAG. FURTHER ANALYSIS REVEALED THAT THE FLAG WAS DUE TO AN OVER-VOLTAGE FAULT BY THE ANALOG FRONT END (AFE) THAT WAS TRIGGERED WHEN A CELL PAIR INCREASED ABOVE THE VOLTAGE THRESHOLD. WHEN AN OVER-VOLTAGE FAULT OCCURS, THE BATTERY IS UNABLE TO CHARGE BUT CAN STILL PROVIDE POWER. THE FLAG WAS REMOVED AFTER ALLOWING THE BATTERY TO DISCHARGE, CAUSING THE VOLTAGE TO DECREASE BELOW THE VOLTAGE THRESHOLD. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO AN OVER VOLTAGE FAULT 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

    PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED VISUAL INSPECTION BUT FAILED FUNCTIONAL TESTING. TI SCREEN CAPTURE REVEALED A COV FLAG ENABLED. AFTER MACCOR TESTING, THE COV FLAG WAS REMOVED AND THE BATTERY WAS ABLE TO BE RECHARGE AND POWER UP THE CONTROLLER TEST BED SET UP. INVESTIGATION IS STILL PENDING. 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 DISPLAYED A SOLID ORANGE LIGHT ON THE BATTERY CHARGER FOR HOURS AND THEN TURNED INTO A BLINKING RED LIGHT. THE BATTERY WAS ATTEMPTED TO BE CHARGED IN MULTIPLE BATTERY CHARGERS WITH THE SAME OUTCOME OF A BLINKING RED LIGHT. THE BATTERY AND THE ASSOCIATED BATTERY CHARGER WERE REPLACED. THE BATTERY WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414747 HEARTWARE VENTRICULAR ASSIST SYSTEM-BATTERY VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1650 00888707000369

    Patients

    Seq Age Sex Outcome Treatment
    1 VAD| VAD