BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY

    MDR report key: 7456662 · Received April 24, 2018

    Report

    Report Number
    3007042319-2018-01583
    Event Type
    Malfunction
    Date Received
    April 24, 2018
    Date of Event
    March 29, 2018
    Report Date
    January 28, 2019
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: TWO BATTERIES WERE RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT (B)(4) MET ALL REQUIREMENT S FOR RELEASE. FAILURE ANALYSIS OF THE RETURNED DEVICES REVEALED THAT THE DEVICES PASSED VISUAL INSPECTION. FUNCTIONAL TESTING OF (B)(4) REVEALED THAT THE BATTERY WAS UNABLE TO CHARGE OR PROVIDE POWER TO A CONTROLLER. THE BATTERY WAS RECEIVED WITHOUT CHARGE DUE TO A PACK UNDER VOLTAGE (PUV) AND CELL UNDER VOLTAGE (CUV) FLAG ENABLED AND THE PRESENT FLAG WAS DISABLED. A CELL-UNDER-VOLTAGE FLAG IS TRIGGERED WHEN A CELL PAIR FALLS BELOW A VOLTAGE THRESHOLD. LIKEWISE, A PACK-UNDER-VOLTAGE FLAG IS TRIGGERED WHEN THE BATTERY PACK FALLS BELOW A VOLTAGE THRESHOLD. CHARGING THE BATTERY WILL CLEAR THE PUV AND CUV FLAG. HOWEVER, THE DISABLED PRESENT FLAG PREVENTS THE BATTERY FROM CHARGING OR PROVIDING POWER. ANALYSIS OF THE DEVICE REVEALED THAT THE MOST LIKELY ROOT CAUSE OF THE DISABLED PRESENT FLAG CAN BE ATTRIBUTED TO A SOLDERING DEFECT. FUNCTIONAL TESTING OF (B)(4) REVEALED THAT THE BATTERY FLASHED RED ON THE BATTERY CHARGER DUE TO A HIGH MAX ERROR. THE MAX ERROR IS AN INDICATOR OF HOW WELL THE BATTERY¿S RELATIVE STATE OF CHARGE (RSOC) IS CALIBRATED. THE BATTERY IS STILL ABLE TO CHARGE AND PROVIDE POWER TO A CONTROLLER. A TENDENCY TO EXCHANGE BATTERIES BEFORE REACHING 25% RELATIVE STATE OF CHARGE (RSOC) MAY CONTRIBUTE TO AN OUT-OF-CALIBRATION CONDITION. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. BASED ON THE AVAILABLE INFORMATION, A POSSIBLE ROOT CAUSE OF THE REPORTED EVENT FO (B)(4) CAN BE ATTRIBUTED TO A SOLDERING DEFECT. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT FOR (B)(4) CAN BE ATTRIBUTED TO A BATTERY THAT IS OUT OF CALIBRATION. THE REPORTED INABILITY OF (B)(4). TO PROVIDE POWER COULD NOT BE CONFIRMED. ADDITIONAL PRODUCTS: BATTERY (B)(4). D10: YES, RETURN DATE: 2018-05-23 H3: YES H6 FDA METHOD CODE(S): 10 H6 FDA RESULTS CODE(S): 114 H6 FDA CONCLUSION CODE(S): 19 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. ADDITIONAL DEVICES ASSOCIATED: BATTERY / (B)(4)/ MODEL # 1650DE / UDI: (B)(4)/ EXP. DATE: 30APR2017. DEVICE AVAILABLE FOR EVALUATION: NO, MFG. DATE: 30APR2016, LABELED FOR SINGLE USE: NO. (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 ALLEGED BATTERIES WERE NOT CHARGING. BOTH BATTERIES WERE CHECKED ON PORT ONE AND PORT TWO OF THE CONTROLLER AND NEITHER PROVIDED POWER. THE INDICATOR LIGHT ON THE BATTERY CHARGER DISPLAY FLASHED RED WHEN BATTERIES WERE PLACED TO CHARGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298490 HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1650DE

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR MCS UNKNOWN VAD