BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY

    MDR report key: 8160165 · Received December 13, 2018

    Report

    Report Number
    3007042319-2018-07110
    Event Type
    Malfunction
    Date Received
    December 13, 2018
    Date of Event
    November 30, 2018
    Report Date
    March 28, 2019
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1903-2018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE EIGHT BATTERIES WERE RETURNED FOR EVALUATION. FAILURE ANALYSIS OF THE RETURNED DEVICES REVEALED THAT THE DEVICES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. THE LOG FILES OF THE CONTROLLER IN USE DURING THE REPORTED EVENT 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. LOG FILE ANALYSIS DID NOT REVEAL ANY PREMATURE POWER SWITCHING EVENTS DURING THE REPORTED EVENT DATE. AS A RESULT, THE REPORTED "POWER SWITCHING" EVENT COULD NOT BE CONFIRMED. ADDITIONALLY, LOG FILE ANALYSIS REVEALED THAT THE BATTERIES DISCHARGED AS EXPECTED WHEN IN USE. AS A RESULT, THE REPORTED "POWER CONSUMPTION ISSUE" EVENT COULD NOT BE CONFIRMED DURING BENCH TESTING; THE BATTERY PERFORMED AS EXPECTED. A POWER SOURCE LUBRICATION PROCEDURE WAS PERFORMED ON HALF THE POWER SOURCES ON 10JUL2018 AND THE OTHER HALF ON 22NOV2018. ADDITIONAL PRODUCTS: BATTERY (B)(6) D10: YES, RETURN DATE: 2019-03-05 H3: YES DEV RTN TO MFR? YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 67 BATTERY (B)(6) D10: YES, RETURN DATE: 2019-03-05 H3: YES DEV RTN TO MFR? YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 67 BATTERY (B)(6) D10: YES, RETURN DATE: 2019-03-05 H3: YES DEV RTN TO MFR? YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 67 BATTERY (B)(6) D10: YES, RETURN DATE: 2019-03-05 H3: YES DEV RTN TO MFR? YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 67 BATTERY (B)(6) D10: YES, RETURN DATE: 2019-03-05 H3: YES DEV RTN TO MFR? YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 67 BATTERY (B)(6) D10: YES, RETURN DATE: 2019-03-05 H3: YES DEV RTN TO MFR? YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 67 BATTERY (B)(6) D10: YES, RETURN DATE: 2019-03-05 H3: YES DEV RTN TO MFR? YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 67 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 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. HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY/ (B)(4)/ MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 2017-01-31, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2016-01-31 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4)/ MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 2018-05-31, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2017-05-31 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY/ (B)(4)/ MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 2016-12-31, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2015-12-31 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4) / MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 2017-06-30, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2016-06-30 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4) / MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 2017-01-31, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2016-01-31 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4) / MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 2016-09-30, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2015-09-30 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4) / MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 2018-02-28, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2017-02-28 (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 PATIENT'S BATTERIES WOULD POWER SWITCH INAPPROPRIATELY, EVEN AFTER BEING PREVIOUSLY SERVICED. IT WAS ALSO REPORTED THAT THE BATTERIES HAD A POWER CONSUMPTION ISSUE. THE BATTERIES WOULD DRAIN TO TWO BARS, THEN PREMATURELY SWITCH TO THE SECOND POWER SOURCE. 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
    1000148 HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY VENTRICULAR (ASSIST) BYPASS DSQ HEARTWARE, INC. 1650DE

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR 1104 - VAD