BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 12342367 · Received August 19, 2021

    Report

    Report Number
    2916596-2021-04372
    Event Type
    Malfunction
    Date Received
    August 19, 2021
    Date of Event
    July 30, 2021
    Report Date
    August 31, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    MAIN INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A DIM PUMP RUNNING LED WAS UNABLE TO BE CONFIRMED. THE HEARTMATE 3 SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6) WAS NOT RETURNED FOR ANALYSIS; HOWEVER, A LOG FILE WAS SUBMITTED FOR REVIEW. A REVIEW OF THE SUBMITTED LOG FILE SHOWED EVENTS SPANNING APPROXIMATELY 3 DAYS (B)(6) 2021 ¿ (B)(6) 2021 PER TIMESTAMP). THE PUMP WAS ABLE TO OPERATE AT SPEEDS ABOVE THE LOW SPEED LIMIT THROUGHOUT THE LOG FILE. THERE WERE NO NOTABLE ALARMS ACTIVE IN THE LOG FILE. PUMP OPERATION WAS NOT AFFECTED. ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2021 STATED THAT THE HEARTMATE 3 SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6) WILL NOT BE RETURNING. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. HEARTMATE III INSTRUCTIONS FOR USE, REV. C, SECTION 8 ENTITLED ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE III PATIENT HANDBOOK, REV. C, SECTION 6 ENTITLED ¿CARING FOR THE EQUIPMENT¿ ADDRESSES HOW TO PROPERLY CARE FOR AND MAINTAIN THE EQUIPMENT FOR PROPER USE. THE PATIENT HANDBOOK CAUTIONS THE 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 WERE REVIEWED FOR THE SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6) AND WAS FOUND TO PASS ALL MANUFACTURING AND QA SPECIFICATIONS BEFORE BEING SHIPPED TO THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GREEN CIRCLES WERE NOT ILLUMINATED ON THE CONTROLLER. THE CONTROLLER WAS EXCHANGED. A REVIEW OF THE LOG FILE REVEALED ROUTINE EVENTS WITH NO NOTABLE ALARM CONDITIONS OR PARAMETER CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238762 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106531 6531063 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR