BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0

    MDR report key: 15809095 · Received November 16, 2022

    Report

    Report Number
    3007042319-2022-08226
    Event Type
    Malfunction
    Date Received
    November 16, 2022
    Date of Event
    November 10, 2022
    Report Date
    March 16, 2023
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707006859
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ### A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE EVALUATION. PRODUCT EVENT SUMMARY: ONE (1) CONTROLLER ((B)(6)), ONE (1) CONTROLLER DC ADAPTER ((B)(6)), TWO (2) CONTROLLER AC ADAPTERS ((B)(6)) AND FIVE (5) BATTERIES ((B)(6)) WERE NOT RETURNED FOR EVALUATION. ONE (1) BATTERY ((B)(6)) WAS 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 BATTERY REVEALED THAT THE DEVICE PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER IN USE DURING THE REPORTED EVENT, (B)(6), CONTAINS 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 FILE REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS INVOLVING (B)(6) AND AN ADAPTER. ANALYSIS OF THE AVAILABLE DATA LOG FILE ALSO REVEALED SEVERAL MOMENTARY DISCONNECTIONS THAT DID NOT RESULT IN PREMATURE POWER SWITCHING EVENTS INVOLVING (B)(6). MOMENTARY DISCONNECTIONS WILL RESULT IN AN AUDIBLE TONE OR 'BEEP'. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. THE POWER SOURCES WERE LUBRICATED PRIOR TO RELEASE. CAPA PR00574181 IS INVESTIGATING MOMENTARY DISCONNECTIONS. ADDITIONAL PRODUCTS: D4: SERIAL #: (B)(6) H3: YES H6: IMG CODE(S): G0403401 H6: FDA METHOD CODE(S): B15, B17 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): D02 D4: SERIAL #: (B)(6) H3: YES H6: IMG CODE(S): G0403401 H6: FDA METHOD CODE(S): B15, B17 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): D02 D4: SERIAL #: (B)(6) H3: YES H6: IMG CODE(S): G0403401 H6: FDA METHOD CODE(S): B15, B17 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): D02 D4: SERIAL #: (B)(6) H3: YES H6: IMG CODE(S): G0403401 H6: FDA METHOD CODE(S): B15, B17 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): D02 D4: SERIAL #: (B)(6) H3: YES H6: IMG CODE(S): G0403401 H6: FDA METHOD CODE(S): B15, B17 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): D02 D4: SERIAL #: (B)(6) D9: YES, RETURN DATE: 09-DEC-2022 H3: YES DEV RTN TO MFR? YES H6: IMG CODE(S): G0403401 H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): D02 D4: SERIAL #: (B)(6) H3: YES H6: IMG CODE(S): G0403401 H6: FDA METHOD CODE(S): B15, B17 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): D02 D4: SERIAL #: (B)(6) H3: YES H6: IMG CODE(S): G0403401 H6: FDA METHOD CODE(S): B15, B17 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): D02 D4: EXPIRATION DATE: 31-DEC-2022 / SERIAL #: (B)(6) H3: YES H4: MFG DATE: 20-DEC-2021 H6: IMG CODE(S): G0403401 H6: FDA METHOD CODE(S): B15, B17 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): D02 INVESTIGATION OF THIS EVENT IS COMPLETED AND THE FILE WILL BE CLOSED. IF NEW INFORMATION IS RECEIVED, THE FILE WILL BE RE-OPENED AND A SUPPLEMENTAL WILL BE SUBMITTED. ### 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. 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

    INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. ADDITIONAL PRODUCTS: BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER DC ADAPTER, MODEL #: 1440, CATALOG #: 1440, EXPIRATION DATE: 30-SEP-2023, SERIAL OR LOT#: (B)(4), UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUATION: NO, DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, MFG DATE:16-AUG-2021, LABELED FOR SINGLE USE: NO, (B)(4); BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER AC ADAPTER, MODEL #: 1430, CATALOG #: 1430, EXPIRATION DATE: 31-OCT-2023, SERIAL OR LOT#: (B)(4), UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUATION: NO, DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, MFG DATE: 23-AUG-2021, LABELED FOR SINGLE USE: NO, (B)(4); BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER AC ADAPTER, MODEL #: 1430 , CATALOG #: 1430, EXPIRATION DATE: 31-OCT-2023, SERIAL OR LOT#: (B)(4), UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUATION: NO, DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, MFG DATE: 23-AUG-2021, LABELED FOR SINGLE USE: NO, (B)(4); BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650, CATALOG #: 1650, EXPIRATION DATE: 31-DEC-2022, SERIAL OR LOT#: (B)(4), UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUATION: NO, DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, MFG DATE: 03-DEC-2021, LABELED FOR SINGLE USE: NO, (B)(4); BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY , MODEL #: 1650, CATALOG #: 1650, EXPIRATION DATE: 31-DEC-2022, SERIAL OR LOT#: (B)(4), UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUATION: NO, DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, MFG DATE: 03-DEC-2021, LABELED FOR SINGLE USE: NO, (B)(4); BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650, CATALOG #: 1650, EXPIRATION DATE: 31-DEC-2022, SERIAL OR LOT#: (B)(4), UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUATION: NO, DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, MFG DATE: 03-DEC-2021, LABELED FOR SINGLE USE: NO, (B)(4); BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650, CATALOG #: 1650, EXPIRATION DATE: 18-DEC-2022, SERIAL OR LOT#: (B)(4), UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUATION: NO, DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, MFG DATE: 03-DEC-2021, LABELED FOR SINGLE USE: NO ,(B)(4); BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650, CATALOG #: 1650, EXPIRATION DATE: 20-DEC-2022, SERIAL OR LOT#: (B)(4), UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUATION: NO, DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, DEVICE MANUFACTURE DATE: MFG DATE: 03-DEC-2021, LABELED FOR SINGLE USE: NO, (B)(4); BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650, CATALOG #: 1650, EXPIRATION DATE: 20-DEC-2022, SERIAL OR LOT#: (B)(4), UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUATION: NO, DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, MFG DATE: 03-DEC-2021, LABELED FOR SINGLE USE: NO (B)(4); 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS POWER SWITCHING ON THE CONTROLLER, CONTROLLER AC ADAPTERS, CONTROLLER DC ADAPTERS AND BATTERIES. THE BATTERIES WERE POWER SWITCHING BEFORE GETTING TO 25 PERCENT CAPACITY ON THE BATTERY. THE PATIENT WOULD HOOK UP TO A NEW BATTERY AND BEFORE IT REACHED LESS THAN 25 PERCENT, IT WOULD SPONTANEOUSLY SWITCH BETWEEN TWO SOURCES. IT WAS NOTED THAT THE PATIENT JUST RECEIVED ALL NEW POWER SOURCES. THE PATIENT COULDN¿T IDENTIFY WHICH BATTERY WAS CAUSING THE POWER SWITCHING BUT REPORTED BEEPING AND FLIPPING BETWEEN POWER SOURCES. ALL INDICATORS WERE WORKING FINE. "DISCONNECTION CODES" WERE NOTED ON MULTIPLE BATTERIES. THE CONTROLLER, CONTROLLER AC ADAPTERS, CONTROLLER DC ADAPTERS AND BATTERIES WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. VENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2837663 HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1420 00888707006859

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male 1103 VAD.