BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 LVAS MINI APICAL CUFF KIT

    MDR report key: 20185868 · Received September 10, 2024

    Report

    Report Number
    2916596-2024-05856
    Event Type
    Malfunction
    Date Received
    September 10, 2024
    Date of Event
    August 26, 2024
    Report Date
    November 22, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013082
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE HEARTMATE 3 EQUIPMENT BEING OPENED ON A TABLE THAT CONTAINED CONTAMINATED TOOLS CANNOT BE CONFIRMED THROUGH THIS EVALUATION. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6). NO FURTHER ISSUES HAVE BEEN REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 5 OF THE IFU, "SURGICAL PROCEDURES", NOTES TO USE CARE WHEN UNPACKING ITEMS, AS SEVERAL OF THE ITEMS MUST BE PLACED IN THE STERILE FIELDS. THIS SECTION PROVIDES INSTRUCTIONS ON HOW TO UNPACK ALL OF THE IMPLANT KIT COMPONENTS IN THE OPERATING ROOM, INCLUDING THE PUMP AND ACCESSORIES TRAY, AND INSTRUCTS THE USER TO PLACE ALL THE STERILE COMPONENTS IN THE STERILE WORK AREA. THIS SECTION ALSO PROVIDES INSTRUCTIONS FOR PREPPING, RUNNING, AND PRIMING THE PUMP. IN ADDITION, SECTION 5 OF THE IFU (UNDER ¿SURGICAL CONSIDERATIONS¿) WARNS THAT DURING THE IMPLANT PROCESS, A COMPLETE BACKUP SYSTEM (IMPLANT KIT AND EXTERNAL COMPONENTS) MUST BE AVAILABLE ON-SITE AND IN CLOSE PROXIMITY FOR USE IN AN EMERGENCY. 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 COMPLETE.

    Description of Event or Problem · 0

    IT WAS ADDITIONALLY CONFIRMED THAT THERE WAS CONCERN FOR USE OF EQUIPMENT AFTER BREACH OF STERILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HEARTMATE 3 EQUIPMENT WAS OPENED ON A TABLE THAT CONTAINED CONTAMINATED TOOLS FROM IMPELLA 5.5 EXPLANT. THE SURGEON/OPERATING ROOM (OR) TEAM OPTED TO USE THE EQUIPMENT ANYWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2329605 HEARTMATE 3 LVAS MINI APICAL CUFF KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 10005877 10348847 00813024013082

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male