BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM-CONTROLLER 2.0

    MDR report key: 7578253 · Received June 7, 2018

    Report

    Report Number
    3007042319-2018-02271
    Event Type
    Malfunction
    Date Received
    June 7, 2018
    Date of Event
    May 7, 2018
    Report Date
    August 5, 2019
    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
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE CONTROLLER (B)(4) WAS NOT RETURNED FOR EVALUATION. SIX BATTERIES(B)(4) WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED TO EVALUATE THE PERFORMANCE OF THE RETURNED DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED BATTERIES REVEALED THAT THE DEVICES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER, (B)(4), 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 THAT WERE DUE TO MOMENTARY DISCONNECTIONS INVOLVING (B)(4) AND POWER SWITCHING EVENTS DUE TO COMMUNICATION ERRORS INVOLVING (B)(4). ANALYSIS OF THE ALARM FILE REVEALED TWO CRITICAL BATTERY ALARMS DUE TO COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES, INVOLVING BATTERIES (B)(4). AS A RESULT, THE REPORTED "POWER SWITCHING" AND "CRITICAL BATTERY ALARMS" EVENTS WERE CONFIRMED. HOWEVER, ANALYSIS OF THE EVENT LOG FILE DID NOT REVEAL ANY LOSS OF POWER TO THE CONTROLLER AND REVIEW OF THE ALARM LOG FILE DID NOT REVEAL ANY POWER DISCONNECT ALARMS, SO THE REPORTED "DOUBLE DISCONNECT" AND "POWER DISCONNECT ALARMS" EVENTS COULD NOT BE CONFIRMED. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE REPORTED POWER SWITCHING EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS AND COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. THE MOST LIKELY ROOT CAUSE OF THE CRITICAL BATTERY ALARM EVENT CAN BE ATTRIBUTED TO COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. ADDITIONAL PRODUCTS: BATTERY / (B)(4). D4 EXPIRATION DATE: 2018-04-30 UDI #: (B)(4). H3: YES H4: MFG DATE: 2017-04-30 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 (B)(4). PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. EXAMINATION OF CONTROLLER LOG FILES SHOWS THAT THE BATTERY WAS NOT INVOLVED ON ANY POWER SWITCHING EVENTS WITHIN THE ANALYZED PERIOD. ADDITIONAL PRODUCTS: BATTERY / (B)(4). EXPIRATION DATE: 2018-04-30 UDI #: (B)(4). H3: YES H4: MFG DATE: 2017-04-30 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 (B)(4). PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. EXAMINATION OF CONTROLLER LOG FILES SHOWS POWER SWITCHING EVENTS DUE TO MOMENTARY DISCONNECT WHERE THE BATTERY WAS INVOLVED WITHIN THE ANALYZED PERIOD. ADDITIONAL PRODUCTS: BATTERY / (B)(4). D4 EXPIRATION DATE: 2018-04-30 UDI #: (B)(4). H3: YES H4: MFG DATE: 2017-04-30 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 (B)(4).PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. EXAMINATION OF CONTROLLER LOG FILES SHOWS POWER SWITCHING EVENTS DUE TO MOMENTARY DISCONNECT WHERE THE BATTERY WAS INVOLVED WITHIN THE ANALYZED PERIOD. ADDITIONAL PRODUCTS: BATTERY / (B)(4). D4 EXPIRATION DATE: 2018-04-30 UDI #: (B)(4). H3: YES H4: MFG DATE: 2017-04-30 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 (B)(4). PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. EXAMINATION OF CONTROLLER LOG FILES SHOWS THAT THE BATTERY WAS NOT INVOLVED ON ANY POWER SWITCHING EVENTS WITHIN THE ANALYZED PERIOD. THE RETURNED BATTERY (B)(4).PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. EXAMINATION OF CONTROLLER LOG FILES SHOWS THAT THE BATTERY WAS NOT INVOLVED ON ANY POWER SWITCHING EVENTS WITHIN THE ANALYZED PERIOD. ADDITIONAL PRODUCTS: BATTERY / (B)(4). D4 EXPIRATION DATE: 2018-05-31 UDI #: (B)(4). H3: YES H4: MFG DATE: 2017-05-31 H6 FDA METHOD CODE(S): 10, 23, 3372, 38 H6 FDA RESULTS CODE(S): 3 213 H6 FDA CONCLUSION CODE(S): 25 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY (B)(4). PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. EXAMINATION OF CONTROLLER LOG FILES SHOWS A CRITICAL BATTERY 1 ALARM AND POWER SWITCHING EVENTS DUE TO COMMUNICATION ERROR WHERE THE BATTERY WAS INVOLVED WITHIN THE ANALYZED PERIOD. ADDITIONAL PRODUCTS: BATTERY / (B)(4). D4 EXPIRATION DATE: 2018-05-31 UDI #: (B)(4). H3: YES H4: MFG DATE: 2019-05-31 H6 FDA METHOD CODE(S): 10, 23, 3372, 38 H6 FDA RESULTS CODE(S): 3 213 H6 FDA CONCLUSION CODE(S): 25 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY (B)(4). PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. EXAMINATION OF CONTROLLER LOG FILES SHOWS A CRITICAL BATTERY 1 ALARM AND POWER SWITCHING EVENTS DUE TO COMMUNICATION ERROR WHERE THE BATTERY WAS INVOLVED WITHIN THE ANALYZED PERIOD. 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

    PRODUCT EVENT SUMMARY: THE CONTROLLER WAS RETURNED FOR EVALUATION. FOUR BATTERIES (B)(6) WERE NOT RETURNED. 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 CONTROLLER REVEALED THAT THE DEVICE PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. THE REPORTED EVENT COULD NOT BE DUPLICATED DURING BENCH TESTING. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER CONTAINED A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15-MINUTE INTERVAL. ANALYSIS OF DATA LOG FILES REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS DUE TO MOMENTARY DISCONNECTIONS INVOLVING (B)(6) AND (B)(6) AND PREMATURE POWER SWITCHING EVENTS DUE TO COMMUNICATION ERRORS INVOLVING (B)(6) AND (B)(6). MOMENTARY DISCONNECTIONS WILL RESULT IN AN AUDIBLE TONE OR "BEEP." ADDITIONALLY, DATA LOG FILES REVEALED RELATIVE STATE OF CHARGE (RSOC) VALUES BETWEEN 101-201 INVOLVING (B)(6), (B)(6), AND (B)(6), WHICH IS INDICATIVE OF COMMUNICATION ERRORS. AS A RESULT, THE REPORTED EVENTS WERE CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED PREMATURE POWER SWITCHING EVENTS CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS AND COMMUNICATION ERRORS. THE MOST LIKELY ROOT CAUSE OF THE REPORTED BEEPS CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS. POSSIBLE ROOT CAUSES OF THE REPORTED COMMUNICATION ERRORS CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS ON THE COMMUNICATION PINS OF THE CONTROLLER, THE CONTROLLER NOT RECEIVING RESPONSES FROM THE BATTERY, AND/OR DUE TO THE PACKET ERROR CHECKING METHOD DETECTING BIT ERRORS. AN INTERNAL INVESTIGATION EVALUATED MOMENTARY DISCONNECTIONS. ADDITIONAL PRODUCTS: D4: CATALOG #: 1650 / SERIAL #: (B)(6). H3: YES DEV RTN TO MFR? YES H6: FDA METHOD CODE(S): 4112 H6: FDA CONCLUSION CODE(S): 67 D4: CATALOG #: 1650 / SERIAL #: (B)(6). H3: YES DEV RTN TO MFR? YES H6: FDA METHOD CODE(S): 4112 H6: FDA RESULTS CODE(S): 213 H6: FDA CONCLUSION CODE(S): 12 D4: CATALOG #: 1650 / SERIAL #: (B)(6). H3: YES DEV RTN TO MFR? YES H6: FDA METHOD CODE(S): 4112 H6: FDA CONCLUSION CODE(S): 12 D4: CATALOG #: 1650 / SERIAL #: (B)(6). H3: YES DEV RTN TO MFR? YES H6: FDA METHOD CODE(S): 4112 H6: FDA CONCLUSION CODE(S): 67 D4: CATALOG #: 1650 / SERIAL #: (B)(6). H3: YES DEV RTN TO MFR? YES H6: FDA METHOD CODE(S): 4112 H6: FDA RESULTS CODE(S): 3213 H6: FDA CONCLUSION CODE(S): 4307 D4: CATALOG #: 1650 / SERIAL #: (B)(6).H3: YES DEV RTN TO MFR? YES H6: FDA METHOD CODE(S): 4112 H6: FDA RESULTS CODE(S): 3213 H6: FDA CONCLUSION CODE(S): 4307 THIS EVENT WAS ASSESSED AND IS BEING REPORTED AS PART OF A RETROSPECTIVE REVIEW OF LOG FILE DATA. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    LOG FILE REVIEW INDICATED THAT TWO OF THE BATTERIES ALSO HAD A COMMUNICATION ERROR.

    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 #: 1650 / EXPIRATION DATE: 2018-04-30. UDI #: (B)(4). RETURN DATE: 2018-05-23. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2017-04-30. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM -BATTERY. BATTERY / (B)(4) /MODEL #: 1650 / EXPIRATION DATE: 2018-04-30. UDI #: (B)(4). RETURN DATE: 2018-05-23. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2017-04-30. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM -BATTERY. BATTERY / (B)(4) /MODEL #: 1650DE / EXPIRATION DATE: 2018-04-30. UDI #: (B)(4). RETURN DATE: 2018-05-23. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2017-04-30. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM -BATTERY. BATTERY / (B)(4) /MODEL #: 1650 / EXPIRATION DATE: 2018-04-30. UDI #: (B)(4). RETURN DATE: 2018-05-23. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2017-04-30. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM -BATTERY. BATTERY / (B)(4) /MODEL #: 1650 / EXPIRATION DATE: 2018-05-31. UDI #: (B)(4). RETURN DATE: 2018-05-23. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2017-05-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM -BATTERY. BATTERY / (B)(4) /MODEL #: 1650 / EXPIRATION DATE: 2018-05-31. UDI #: (B)(4). RETURN DATE: 2018-05-23. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2019-05-31. (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 THE VENTRICULAR ASSIST DEVICE (VAD) CONTROLLER EXHIBITED POWER SWITCHING, DOUBLE DISCONNECT, AND POWER DISCONNECT ALARMS. THE ASSOCIATED BATTERIES EXHIBITED POWER SWITCHING, POWER DISCONNECT, AND TWO EXHIBITED INAPPROPRIATE CRITICAL BATTERY ALARMS. THE BATTERIES WERE EXCHANGED AND THE CONTROLLER REMAIN 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
    419785 HEARTWARE VENTRICULAR ASSIST SYSTEM-CONTROLLER 2.0 VENTRICULAR (ASSIST) BYPASS DSQ HEARTWARE, INC. 1420 00888707000420

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR 1103 VAD