BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY

    MDR report key: 11706236 · Received April 22, 2021

    Report

    Report Number
    3007042319-2021-03301
    Event Type
    Malfunction
    Date Received
    April 22, 2021
    Date of Event
    April 15, 2021
    Report Date
    January 27, 2022
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707005708
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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: TWO (2) BATTERIES ((B)(6)) 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. LOG FILES WERE NOT AVAILABLE FOR ANALYSIS. FAILURE ANALYSIS OF THE RETURNED BATTERIES REVEALED THAT THE DEVICES PASSED VISUAL INSPECTION. FUNCTIONAL TESTING OF (B)(6) REVEALED THAT THE BATTERY WAS UNABLE TO CHARGE OR PROVIDE POWER DUE TO AN ENABLED ZERO-VOLT CHARGE (ZVCHG) FIELD-EFFECT TRANSISTOR (FET). THE GAS GAUGE IS NOT PROGRAMMED TO USE THE ZVCHG FET, WHICH INDICATES THAT THE BATTERY UNINTENTIONALLY ENABLED THE FET. FURTHER INVESTIGATION USING A REPRESENTATIVE SAMPLE REVEALED THAT THE REPORTED EVENT CAN BE REPLICATED BY EXPOSING THE BATTERY TO ELECTROSTATIC DISCHARGE (ESD). THE ZVCHG FET DISABLES THE CHARGE AND DISCHARGE FETS, RENDERING THE BATTERY INOPERABLE. FUNCTIONAL TESTING OF (B)(6) REVEALED THAT THE BATTERY WAS UNABLE TO CHARGE OR PROVIDE POWER DUE TO DISABLED CHARGE AND DISCHARGE FIELD-EFFECT TRANSISTORS (FETS) AND AN ENABLED SAFETY FLAG. THIS IS AN ABNORMAL ARRANGEMENT OF THE BATTERY CONTROL FETS, INDICATIVE OF A FAULT OF THE MAIN INTEGRATED CIRCUIT THAT CONTROLS THE BATTERIES. AN ATTEMPT TO RESET THE MAIN INTEGRATED CIRCUIT WAS ABLE TO REESTABLISH THE BATTERY¿S FUNCTIONALITY. FURTHER INVESTIGATION USING A REPRESENTATIVE SAMPLE REVEALED THAT THE REPORTED EVENT CAN BE REPLICATED BY EXPOSING THE BATTERY TO ESD. IF AN INOPERABLE BATTERY IS CONNECTED TO THE CONTROLLER A POWER DISCONNECT ALARM IS TRIGGERED. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO AN ESD EVENT. CAPA PR00519785 IS INVESTIGATING BATTERY FAILURES RELATED TO ESD. ADDITIONAL PRODUCTS: D4: SERIAL #: (B)(6) D9: YES, RETURN DATE: 02-JUN-2021 H3: YES DEV RTN TO MFR? YES H6: IMG CODE(S): G02013 H6: FDA METHOD CODE(S): B01 H6: FDA RESULTS CODE(S): C0302 H6: FDA CONCLUSION CODE(S): D06 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. 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

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR AN UPDATE TO THE DEVICE EVALUATION AND INVESTIGATION COMPLETION. THE PRODUCT EVENT SUMMARY AND THE ANNEX C AND D CODES HAVE BEEN UPDATED. PRODUCT EVENT SUMMARY: BASED ON AN INVESTIGATION CONDUCTED UNDER CAPA PR00519785, THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT HAS BEEN ATTRIBUTED TO THE BATTERY CONNECTOR INTERFACE DESIGN WHICH DOES NOT GUARANTEE THE DESIRED CONNECTION ANGLE IN SOME USE CONDITIONS." ADDITIONAL PRODUCTS: D4: SERIAL #: (B)(6) H6: FDA RESULTS CODE(S): C02 H6: FDA CONCLUSION CODE(S): D01 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 · 1

    ADDITIONAL PRODUCTS: BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650, CATALOG #: 1650, EXPIRATION DATE: 30-SEP-2021, SERIAL #: (B)(4), UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION: NO. MFG DATE: 28-SEP-2020.LABELED FOR SINGLE USE: NO. PATIENT IME CODE(S): (B)(4). IMF CODE(S): (B)(4). INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERIES WEREN'T RECOGNIZED BY THE CONTROLLER AND SOUNDED AN ALARM ON THE CONTROLLER. THE BATTERIES WERE EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602977 HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1650 00888707005708

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 1104 VAD