BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 14 VOLT LITHIUM ION BATTERY SET

    MDR report key: 12218865 · Received July 23, 2021

    Report

    Report Number
    2916596-2021-04177
    Event Type
    Malfunction
    Date Received
    July 23, 2021
    Date of Event
    November 6, 2020
    Report Date
    July 26, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010692
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE 14-VOLT BATTERY HAVING A LARGE NUMBER OF CYCLES WAS CONFIRMED. THE RETURNED 14-VOLT BATTERY (SERIAL NUMBER (B)(4)) HAD ITS PARAMETERS MEASURED UPON ARRIVAL, AND THE CYCLE COUNT WAS OBSERVED TO BE 1033 CYCLES. THE BATTERY WAS ATTEMPTED TO BE CALIBRATED; HOWEVER, THE BATTERY FAILED TO CALIBRATE. THE BATTERY ALSO FAILED TO COMPLETE A CHARGE/DISCHARGE CYCLE TEST. THE BATTERY¿S CYCLE COUNT CONTINUED TO RAPIDLY INCREASE THROUGHOUT EXTENDED TESTING, INDICATING AN ISSUE WITH THE BATTERY¿S PCB. FURTHER TROUBLESHOOTING WAS PERFORMED AT MCS PLEASANTON, AND ONE OF THE BATTERY¿S CONTROL COMPONENTS ON ITS PCB WAS FOUND TO BE DAMAGED. AT THIS POINT, THE BATTERY DID NOT RESPOND TO BEING PLACED WITHIN A TEST UBC, AND THE FUEL GAUGE DID NOT SHOW ANY LIGHTS, INDICATING THAT THE BATTERY HAD BECOME INOPERABLE. DAMAGE TO THE BATTERY¿S PCB WAS DETERMINED TO BE THE ROOT CAUSE OF THE REPORTED EVENT; HOWEVER, THE ROOT CAUSE OF HOW THE BATTERY BECAME DAMAGED WAS UNABLE TO BE CONCLUSIVELY DETERMINED. THE HEARTMATE 3 PATIENT HANDBOOK (REV. C, SECTION 3 ¿POWERING THE SYSTEM¿) INSTRUCTS USERS ON HOW TO CALIBRATE 14-VOLT BATTERIES AND TO AVOID USING UNCALIBRATED BATTERIES. IF A BATTERY IS UNABLE TO BE CALIBRATED, CONTACT ABBOTT FOR ASSISTANCE. THE HEARTMATE 3 PATIENT HANDBOOK (REV. C, SECTION TITLED "EMERGENCY CONTACT LIST") CAUTIONS USERS TO CALL THEIR HOSPITAL CONTACTS IF THEY THINK, FOR ANY REASON, ANY PORTION OF THEIR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR THEY ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. THE DEVICE HISTORY RECORDS FOR THE RETURNED 14-VOLT BATTERY, SERIAL NUMBER (B)(4)) WERE REVIEWED, AND THE BATTERY WAS OBSERVED TO PASS ALL INITIAL MANUFACTURING TESTS (PER THE BATTERY INSPECTION DATASHEET). THE BATTERY WAS OBSERVED TO HAVE A CYCLE COUNT OF 1 AFTER PASSING ALL REQUIRED TESTING ON 23JUL2020. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY KEPT TRIGGERING THE CALIBRATION ALARM WHILE CHARGING. THE BATTERY WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1117774 HEARTMATE 14 VOLT LITHIUM ION BATTERY SET VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 2465 SU197-B098 00813024010692

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR