BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 16744817 · Received April 14, 2023

    Report

    Report Number
    2916596-2023-01886
    Event Type
    Malfunction
    Date Received
    April 14, 2023
    Date of Event
    March 28, 2023
    Report Date
    July 6, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011286
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT THE PUMP RUNNING LED BEING OFF WAS UNABLE TO BE CONFIRMED. THE HEARTMATE II 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 FILES SHOWED EVENTS SPANNING APPROXIMATELY 3 DAYS ((B)(6) 2023 PER TIMESTAMP). THE PUMP WAS ABLE TO MAINTAIN SPEEDS ABOVE THE LOW SPEED LIMIT THROUGHOUT THE LOG FILE. THERE WERE NO NOTABLE ALARMS ACTIVE IN THE LOGFILE OR EVENTS THAT WOULD INDICATE THE PUMP RUNNING LED WAS OFF. PUMP OPERATION WAS NOT AFFECTED, AND THE DEVICE APPEARED TO FUNCTION AS INTENDED. MULTIPLE GOOD FAITH EFFORT ATTEMPTS WERE MADE ASKING FOR THE CAUSE OF THE PUMP RUNNING LED TO NOT ILLUMINATE; HOWEVER, NO RESPONSE WAS RECEIVED. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. 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. HEARTMATE II INSTRUCTIONS FOR USE SECTION 8 ENTITLED ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE II PATIENT HANDBOOK SECTION 6 ENTITLED ¿CARING FOR THE EQUIPMENT¿ ADDRESSES HOW TO PROPERLY CARE FOR, MAINTAIN, AND STORE 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. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED. SECTION E1: REPORTER POSTAL OFFICE OR ZIP CODE: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SUDDEN DIZZINESS AND WEAKNESS. NO ALARMS OCCURRED BUT IT WAS THOUGHT THAT THE GREEN CIRCLE OF LIFE WENT OUT AND IT IS CURRENTLY BACK ON. THERE WERE NO OTHER UNUSUAL EVENTS RECORDED IN THE LOG FILES EVENT HISTORY. THE DEVICE OPERATED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143931 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106762 8749673 00813024011286

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male