BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 15005510 · Received July 13, 2022

    Report

    Report Number
    2916596-2022-12001
    Event Type
    Injury
    Date Received
    July 13, 2022
    Date of Event
    June 17, 2022
    Report Date
    July 18, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. A CORRELATION BETWEEN THE DEVICE AND THE REPORT OF INFECTION COULD NOT BE CONCLUSIVELY DETERMINED. INFECTION IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. INFECTION HAS BEEN PREVIOUSLY INVESTIGATED AND WILL CONTINUE TO BE MONITORED THROUGH QUALITY DATA REVIEWS, WHICH ARE CONDUCTED ON PRODUCTION AND POST PRODUCT SIGNALS TO EVALUATE IF PRODUCTS ARE CONFORMING TO PRODUCT REQUIREMENTS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED FROM THE CLINIC ON (B)(6) 2022 DUE TO PURULENT DRAINAGE AND ABDOMINAL PAIN. THE PATIENT UNDERWENT A DRIVELINE DEBRIDEMENT ON (B)(6) 2022. THE WOUND CULTURES CAME BACK POSITIVE FOR CORYNEBACTERIUM. PATIENT WAS DISCHARGED HOME ON (B)(6) 2022 ON IV VANCOMYCIN 1G Q 12HRS. ANTIBIOTIC STOP DATE WAS SET TO BE (B)(6) 2022. NO OTHER PATIENT ISSUES OR CONCERNS WERE NOTED DURING ADMISSION. THE PUMP REPORTEDLY FUNCTIONED APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2060629 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 7823822 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Male Hospitalization| L| R