BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0

    MDR report key: 7545429 · Received May 25, 2018

    Report

    Report Number
    3007042319-2018-02085
    Event Type
    Malfunction
    Date Received
    May 25, 2018
    Date of Event
    April 22, 2018
    Report Date
    December 4, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000475
    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 CONTROLLER (CON315807) WAS NOT RETURNED FOR EVALUATION. SIX (6) BATTERIES (BAT589933, BAT590143, BAT590139, BAT589973, BAT590138, BAT590136) WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED BATTERIES REVEALED THAT THE DEVICES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. THE BATTERIES WERE 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 BATTERIES' INTERNAL LOG REVEALED THAT A CELL PAIR, AT ONE POINT IN TIME, PASSED THE VOLTAGE THRESHOLD. WHEN THIS OCCURS, THE BATTERIES WILL NOT CHARGE UNTIL THE VOLTAGE DECREASES BELOW THE THRESHOLD. HOWEVER, THE BATTERIES WERE RECEIVED WITH NO FLAGS ENABLED. IF THE BATTERIES REMAIN 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. LOG FILE ANALYSIS REVEALED ONE CONTROLLER POWER UP AND AN ASSOCIATED MOTOR START EVENT ON 04/22/18 AT 08:21:16. THE POWER SOURCES ATTACHED BEFORE THE LOSS OF POWER REVEALED THAT BAT590136 ON POWER PORT 1 WITH 86% RELATIVE STATE OF CHARGE (RSOC) AND BAT590143 ON P OWER PORT 2 WITH 88% RSOC. THE POWER SOURCES ATTACHED AFTER THE LOSS OF POWER WERE CAC ADAPTER ON POWER PORT 1 AND BAT590136 ON POWER PORT 2. THE CONTROLLER REMAINED WITHOUT POWER FOR 11 SECONDS. NO ANOMALIES WERE RECORDED BEFORE THE LOSS OF POWER. AS A RESULT, THE REPORTED CONTROLLER POWER UP AND BATTERIES NOT CHARGING WERE CONFIRMED. HOWEVER, THE REPORTED BATTERIES WITH NO POWER COULD NOT BE CONFIRMED. A POSSIBLE ROOT CAUSE OF THE LOSS OF POWER CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES AND/OR TO AN INTERMITTENT DISCONNECTION ON ONE OR BOTH POWER SOURCES. THE MOST LIKELY ROOT CAUSE OF THE REPORTED NOT CHARGING CAN BE ATTRIBUTED TO AN OVERVOLTAGE FAULT BY THE ANALOG FRONT END (AFE) INTEGRATED CIRCUIT. BASED ON AN INVESTIGATION, BATTERIES WITH A CELL OVER VOLTAGE CONDITION CAN BE ATTRIBUTED TO BATTERY CHARGERS ASSEMBLED WITH INCORRECT INDUCTORS. ADDITIONAL PRODUCTS: BATTERY / BAT589933 H3: YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 131 H6 FDA CONCLUSION CODE(S): 4307 BATTERY / BAT590143 H3: YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 131 H6 FDA CONCLUSION CODE(S): 4307 BATTERY / BAT590139 H3: YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 131 H6 FDA CONCLUSION CODE(S): 4307 BATTERY / BAT589973 H3: YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 131 H6 FDA CONCLUSION CODE(S): 4307 BATTERY / BAT590138 H3: YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 131 H6 FDA CONCLUSION CODE(S): 4307 BATTERY / BAT590136 H3: YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 131 H6 FDA CONCLUSION CODE(S): 4307 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. OTHER DEVICES INVOLVED IN THIS EVENT: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2018-11-30. UDI #: (B)(4). RETURN DATE: 2018-05-16. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2017-11-30. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2018-11-30. UDI #: (B)(4). RETURN DATE: 2018-05-15. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2017-11-30. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2018-11-30. UDI #: (B)(4). RETURN DATE: 2018-05-16. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2017-11-30. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2018-11-30. UDI #: (B)(4). RETURN DATE: 2018-05-16. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2017-11-30. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2018-11-30. UDI #: (B)(4). RETURN DATE: 2018-05-16. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2017-11-30. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2018-11-30. UDI #: (B)(4). RETURN DATE: 2018-05-16. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2017-11-30. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CONTROLLER POWER UP AND AN ASSOCIATED PUMP START EVENT INDICATING A LOSS OF POWER TO THE CONTROLLER. IT WAS SUSPECTED THAT THE LOSS OF POWER COULD BE DUE TO THE BATTERIES. SIX BATTERIES WERE TESTED ON THE CONTROLLER PORT AND NO POWER WAS PROVIDED. THE BATTERIES WERE EXCHANGED, AND THE CONTROLLER REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388520 HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1420 00888707000475

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR 1103 VAD