BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0

    MDR report key: 7161519 · Received January 3, 2018

    Report

    Report Number
    3007042319-2018-00056
    Event Type
    Malfunction
    Date Received
    January 3, 2018
    Date of Event
    December 10, 2017
    Report Date
    October 2, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000420
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1903-2018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCTS: BATTERY (B)(4). FDA RESULTS CODE(S): 3213. FDA CONCLUSION CODE(S): 25 BATTERY (B)(4). DEVICE RETURNED?: YES. FDA METHOD CODE(S): 10, 4112. FDA RESULTS CODE(S): 3213. FDA CONCLUSION CODE(S): 25 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. INVESTIGATION IS ONGOING. 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 · 0

    CORRECTIONS: A5, D4. CONTROLLER 2.0 (B)(4). PRODUCT EVENT SUMMARY: THE RETURNED CONTROLLER PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. INVESTIGATION IS ONGOING. ADDITIONAL PRODUCTS: BATTERY (B)(4). D10: YES, RETURN DATE: 2017-12-29 H3: YES H6 FDA METHOD CODE(S): 10, 23, 3372, 38 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 71 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED EXTERNAL VISUAL INSPECTION AND FUNCTIONAL TESTING. INVESTIGATION IS ONGOING. BATTERY(B)(4). D10: YES, RETURN DATE: 2017-12-29 H3: NO H6 FDA RESULTS CODE(S): 3233 H6 FDA CONCLUSION CODE(S): 11 BATTERY (B)(4). D10: YES, RETURN DATE: 2017-12-29 H3: YES H6 FDA METHOD CODE(S): 10, 23, 3372, 38 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 25 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED EXTERNAL VISUAL INSPECTION AND FUNCTIONAL TESTING. INVESTIGATION IS ONGOING. BATTERY (B)(4). D10: YES, RETURN DATE: 2017-12-29 H3: YES H6 FDA METHOD CODE(S): 10, 23, 3372, 38 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 25 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED EXTERNAL VISUAL INSPECTION AND FUNCTIONAL TESTING. INVESTIGATION IS ONGOING. BATTERY (B)(4). D10: YES, RETURN DATE: 2017-12-29 H3: YES H6 FDA METHOD CODE(S): 10, 23, 3372, 38 H6 FDA RESULTS CODE(S): 131 H6 FDA CONCLUSION CODE(S): 25 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED EXTERNAL VISUAL INSPECTION BUT FAILED FUNCTIONAL TESTING. INVESTIGATION IS ONGOING. 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 · 0

    H6 FDA CONCLUSION CODE(S), BAT218507: H6, BAT218509: H6, BAT219036: H6 PRODUCT EVENT SUMMARY: THE CONTROLLER ((B)(4)) AND FIVE BATTERIES (BAT218327, BAT218491, BAT218507, BAT218509, BAT219036) 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 REVEALED THAT THE RETURNED CONTROLLER AND BATTERIES PASSED VISUAL EXAMINATION. FUNCTIONAL TESTING REVEALED THAT (B)(4), BAT218327, BAT218507, BAT218491 AND BAT218509 PASSED FUNCTIONAL TESTING. A REVIEW OF BAT218491'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. FUNCTIONAL TESTING REVEALED THAT BAT219036 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. IF A BATTERY REMAINS CONNECTED TO THE BATTERY CHARGER WITH A CELL-OVER-VOLTAGE FLAG, THE BATTERY CHARGER STATUS INDICATOR WILL FLASH RED AFTER EIGHT HOURS DUE TO A CHARGE TIME-OUT. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER CONTAINED A SOFTWARE WITH A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15-MINUTE INTERVAL. ANALYSIS OF THE DATA LOG FILES REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS DUE TO MOMENTARY DISCONNECTIONS INVOLVING BAT218327, BAT218491, BAT218507 AND BAT218509. MOMENTARY DISCONNECTION WILL RESULT IN AN AUDIBLE TONE OR "BEEP". AS A RESULT, THE REPORTED EVENTS WERE CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE POWER SWITCHING AND BEEPING EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. AN INTERNAL INVESTIGATION IS OPEN TO EVALUATE MOMENTARY DISCONNECTIONS. THE MOST LIKELY ROOT CAUSE OF REPORTED FLASHING RED CAN BE ATTRIBUTED TO AN OVERVOLTAGE FAULT DETECTED BY THE ANALOG FRONT END (AFE) INTEGRATED CIRCUIT. ADDITIONAL PRODUCTS: BATTERY BAT218327, H6 FDA CONCLUSION CODE(S): 12; BATTERY BAT218491, H6 FDA RESULTS CODE(S): 131, H6 FDA CONCLUSION CODE(S): 12, 4307 BATTERY BAT218507, H6 FDA CONCLUSION CODE(S): 12, BATTERY BAT218509, H6 FDA CONCLUSION CODE(S): 12; BATTERY BAT219036, 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: 2017-05-31. (B)(4). MFG DATE: 2016-05-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY. BATTERY/(B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2017-05-31. (B)(4). MFG DATE: 2016-05-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY. BATTERY/(B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2017-05-31. (B)(4). MFG DATE: 2016-05-31. HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY. BATTERY/(B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2017-05-31. (B)(4). MFG DATE: 2016-05-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY. BATTERY/(B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2017-06-30. (B)(4). MFG DATE: 2016-06-30. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONTROLLER EXHIBITED POWER SWITCHING. IN ADDITION, THE BATTERY CHARGER STATUS ON TWO BATTERIES WERE FLASHING RED WHEN CONNECTED; THREE BATTERIES WOULD OCCASIONALLY BEEP AND CHANGE TO ANOTHER BATTERY PORT WHEN CONNECTED TO THE CONTROLLER. THE CONTROLLER AND BATTERIES WERE EXCHANGED. A PUMP STOP WAS NOTED TO HAVE OCCURRED DURING THE EXCHANGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4288 HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1420 00888707000420

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR 1104 VAD