BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY

    MDR report key: 10123094 · Received June 5, 2020

    Report

    Report Number
    3007042319-2020-03430
    Event Type
    Malfunction
    Date Received
    June 5, 2020
    Date of Event
    May 30, 2020
    Report Date
    July 22, 2020
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000369
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1903-2018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE EVALUATION. PRODUCT EVENT SUMMARY: FOUR BATTERIES 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 INSPECTION AND FUNCTIONAL TESTING. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER IN USE DURING THE REPORTED EVENT CONTAINED 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 FOUR BATTERIES. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. A POWER SOURCE LUBRICATION PROCEDURE HAD BEEN PERFORMED ON ONE BATTERY IN ACCORDANCE WITH THE REQUIREMENTS UNDER FSCA CVG-18-Q4-19 ON 06-DEC-2018. A POWER SOURCE LUBRICATION PROCEDURE HAD BEEN PERFORMED ON TWO BATTERIES IN ACCORDANCE WITH THE REQUIREMENTS UNDER FSCA CVG-18-Q4-19 ON 19-FEB-2019. THERE IS NO EVIDENCE OF A POWER SOURCE LUBRICATION PROCEDURE PERFORMED ON THE THIRD BATTERY. THE MOST LIKELY ROOT CAUSE OF THE REPORTED PREMATURE POWER SWITCHING EVENT AFTER LUBRICATION CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS DUE TO TEMPORARY CORROSION OF THE CONTROLLER-PORT/POWER-SOURCE PINS. THE MOST LIKELY ROOT CAUSE OF THE REPORTED POWER SWITCHING EVENT PRIOR TO LUBRICATION CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERY. CAPA PR00389403 INVESTIGATED MOMENTARY DISCONNECTIONS PRIOR TO LUBRICATION SERVICING. ADDITIONAL PRODUCTS: (B)(6) D10: YES, RETURN DATE: 16-JUN-2020 H3: YES DEV RTN TO MFR? YES H6: FDA METHOD CODE(S): 10, 4112 H6: FDA RESULTS CODE(S): 3213, 213 H6: FDA CONCLUSION CODE(S): 12, 133 (B)(6) D10: YES, RETURN DATE: 16-JUN-2020 H3: YES DEV RTN TO MFR? YES H6: FDA METHOD CODE(S): 10, 4112 H6: FDA RESULTS CODE(S): 3213, 213 H6: FDA CONCLUSION CODE(S): 4307, 133 (B)(6) D10: YES, RETURN DATE: 16-JUN-2020 H3: YES DEV RTN TO MFR? YES H6: FDA METHOD CODE(S): 10, 4112 H6: FDA RESULTS CODE(S): 3213, 213 H6: FDA CONCLUSION CODE(S): 4307, 133 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

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANS PLANTATION 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. ADDITIONAL PRODUCTS: PRODUCT NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 31-DEC-2018 / SERIAL OR LOT#: (B)(4) / UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION?: NO DEVICE EVALUATED BY MANUFACTURER?: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 18-DEC-2017. DEVICE LABELED FOR SINGLE USE?: NO. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERIES EXHIBITED POWER SWITCHING. THE BATTERIES WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586365 HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY VENTRICULAR (ASSIST) BYPASS DSQ HEARTWARE, INC. 1650DE 00888707000369

    Patients

    Seq Age Sex Outcome Treatment
    1 1104 VAD