BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY

    MDR report key: 6795261 · Received August 15, 2017

    Report

    Report Number
    3007042319-2017-02667
    Event Type
    Malfunction
    Date Received
    August 15, 2017
    Date of Event
    July 13, 2017
    Report Date
    May 2, 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
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: FOUR (4) 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. REVIEW OF THE BATTERIES' MANUFACTURING RECORDS CONFIRMED THAT THE ASSOCIATED DEVICES MET ALL REQUIREMENTS FOR RELEASE. FAILURE ANALYSIS OF THE RETURNED DEVICES REVEALED THAT THE BATTERIES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. ALL FOUR BATTERIES DISCHARGED AS EXPECTED. LOG FILE ANALYSIS REVEALED THAT THE BATTERY DISCHARGED AS EXPECTED WHEN IN USE. THE REPORTED "DEPLETED BATTERY CAPACITY WHEN THE AC ADAPTER WAS CONNECTED " COULD NOT BE CONFIRMED. ANALYSIS OF THE DATA LOG FILES REVEALED MOMENTARY DISCONNECTIONS THAT DID NOT LEAD TO PREMATURE POWER SWITCHING INVOLVING (B)(6). THE REPORTED ¿INTERMITTENT POWER DISCONNECTION ALONG WITH POTENTIAL POWER SWITCHING¿ EVENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED PREMATURE POWER SWITCHING, AND INTERMITTENT POWER DISCONNECTION EVENTS CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. ADDITIONAL PRODUCTS: D4: SERIAL #: (B)(6). D10: YES, RETURN DATE: 21-DEC-2018 H3: YES DEV RTN TO MFR? YES H6: FDA METHOD CODE(S): 10, 3331, 4112 H6: FDA RESULTS CODE(S): 3213 H6: FDA CONCLUSION CODE(S): 12 D4: SERIAL #: (B)(6). D10: YES, RETURN DATE: 21-DEC-2018 H3: YES DEV RTN TO MFR? YES H6: FDA METHOD CODE(S): 10, 3331, 4112 H6: FDA RESULTS CODE(S): 3213 H6: FDA CONCLUSION CODE(S): 12 D4: SERIAL #: (B)(6). D10: YES, RETURN DATE: 21-DEC-2018 H3: YES DEV RTN TO MFR? YES H6: FDA METHOD CODE(S): 10, 3331, 4112 H6: FDA RESULTS CODE(S): 3213 H6: FDA CONCLUSION CODE(S): 12. 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

    (B)(4). HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    OTHER DEVICES INVOLVED IN THIS EVENT: (B)(4) - BATTERY. THE BATTERIES WERE NOT RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS CONFIRMED THAT THE ASSOCIATED DEVICES MET ALL REQUIREMENTS FOR RELEASE. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER CONTAINED THE SOFTWARE MASTER RECORD (SMR) SOFTWARE. THE SOFTWARE UPGRADE 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 LOGS DID NOT REVEAL SIGNIFICANT CHANGES IN BATTERY CAPACITY OF ANY OF THE BATTERIES CONNECTED TO A POWER PORT OF THE CONTROLLER WHEN AN AC ADAPTOR WAS CONNECTED TO THE OTHER POWER PORT. AS A RESULT, THE REPORTED "DEPLETED INTERMITTENT POWER DISCONNECTIONS WHEN A CONTROLLER AC ADAPTER WAS CONNECTED" COULD NOT BE CONFIRMED. ANALYSIS OF THE DATA LOG FILES REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES ((B)(4)). THE PATIENT MAY HAVE PERCEIVED THE MOMENTARY DISCONNECTIONS AS INTERMITTENT POWER DISCONNECTIONS SINCE MOMENTARY DISCONNECTIONS WILL RESULT IN AN AUDIBLE TONE. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERY. AN INTERNAL INVESTIGATION IS REVIEWING MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. 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 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 WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD FOUR BATTERIES THAT WERE NOT WORKING PROPERLY. ONE OF THE BATTERIES EXPERIENCED INTERMITTENT POWER DISCONNECTION ALONG WITH POTENTIAL POWER SWITCHING. THE OTHER THREE BATTERIES ALL DEPLETED BATTERY CAPACITY OVERNIGHT WHEN THE AC ADAPTOR WAS CONNECTED, THIS OCCURRED ON TWO DIFFERENT OCCASIONS. THE BATTERIES WOULD THEN RECHARGE TO FULL POWER WITHIN MINUTES ON THE CHARGER. ALL FOUR 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
    574593 HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR