BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM-BATTERY

    MDR report key: 7167642 · Received January 5, 2018

    Report

    Report Number
    3007042319-2018-00089
    Event Type
    Malfunction
    Date Received
    January 5, 2018
    Date of Event
    December 13, 2017
    Report Date
    July 25, 2018
    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
    LU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED EXTERNAL VISUAL INSPECTION AND FUNCTIONAL TESTING. INVESTIGATION IS ONGOING. ADDITIONAL PRODUCTS: BATTERY (B)(4). D10: YES, RETURN DATE: 2018-02-19 H3: YES H6 FDA METHOD CODE(S): 10, 23, 3372, 38 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 71 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED EXTERNAL VISUAL INSPECTION AND FUNCTIONAL TESTING. INVESTIGATION IS ONGOING. BATTERY (B)(4). D10: YES, RETURN DATE: 2018-02-19 H3: YES H6 FDA METHOD CODE(S): 10, 23, 3372, 38 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 71 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED EXTERNAL VISUAL INSPECTION AND FUNCTIONAL TESTING. INVESTIGATION IS ONGOING. BATTERY (B)(4). D10: YES, RETURN DATE: 2018-02-19 H3: YES H6 FDA METHOD CODE(S): 10, 23, 3372, 38 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 71 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED EXTERNAL VISUAL INSPECTION AND FUNCTIONAL TESTING. INVESTIGATION IS ONGOING. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. 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 IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES 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 REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT 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

    PRODUCT EVENT SUMMARY: FOUR BATTERIES ((B)(4)) 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 ((B)(4)) 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. LOG FILES REVEALED THAT THE BATTERIES DISCHARGED AS EXPECTED WHEN IN USE. THE REPORTED EVENT COULD NOT BE CONFIRMED. HOWEVER, ANALYSIS OF THE DATA LOG FILES REVEALED PREMATURE POWER SWITCHING EVENTS DUE TO MOMENTARY DISCONNECTIONS INVOLVING (B)(4). THIS OBSERVATION WAS MOST LIKELY PERCEIVED BY THE PATIENT AS THE REPORTED POWER CONSUMPTION. BASED ON AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE POWER SWITCHING EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. (B)(4). MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. 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 IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES 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 REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT 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. OTHER DEVICES INVOLVED IN THIS EVENT: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿BATTERY, BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2015-10-31 UDI #: (B)(4), MFG DATE: 2014-10-31. HEARTWARE VENTRICULAR ASSIST SYSTEM ¿BATTERY, BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2015-10-31, UDI #: (B)(4), MFG DATE: 2014-10-31. HEARTWARE VENTRICULAR ASSIST SYSTEM ¿BATTERY, BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2015-10-31 UDI #: (B)(4), MFG DATE: 2014-10-31, 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 WERE NOT HOLDING A CHARGE. THEY WERE PROVIDING POWER FOR LESS THAN TWO HOURS. THE BATTERIES WILL BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12581 HEARTWARE VENTRICULAR ASSIST SYSTEM-BATTERY VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1650DE

    Patients

    Seq Age Sex Outcome Treatment
    1 MCS UNKNOWN VAD