BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 9805118 · Received March 9, 2020

    Report

    Report Number
    2916596-2020-01064
    Event Type
    Injury
    Date Received
    March 9, 2020
    Date of Event
    February 15, 2020
    Report Date
    March 9, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEARTMATE 3 LVAS WAS IMPLANTED DURING THE (B)(6) CLINICAL TRIAL, IDE# (B)(4). FDA APPROVAL FOR HEARTMATE 3 LVAS WAS RECEIVED ON 23 AUGUST 2017. THE TRIAL IS LOCKED. THE GTIN UNIQUE DEVICE IDENTIFIER FOR THE COMMERCIAL HEARTMATE3 LVAS IS (B)(4). 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 · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED FOR INCREASED DRIVELINE DRAINAGE AND REDNESS. IT WAS NOTED THAT THERE WAS WORSENING TENDERNESS AT THE DRIVELINE SITE. REPEAT WOUND CULTURE GREW RARE ENTEROBACTER CLOACAE COMPLEX AND ONE COLONY ON ONE PIECE OF MEDIA OF BACILLUS SPECIES, NOT BACILLUS ANTHRACIS. DURING HOSPITALIZATION PATIENT RECEIVED CEFEPIME 2G Q 12 HOURS, UNDERWENT DRIVELINE REVISION ON (B)(6) 2020 AND WOUND VAC PLACED (B)(6) 2020. PATIENT DISCHARGED ON (B)(6) 2020 WITH PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE FOR CEFEPIME INFUSION AND ON ORAL CLINDAMYCIN. IT WAS PLANNED FOR THE PATIENT TO BE FOLLOWED BY INFECTIOUS DISEASE (ID). NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269389 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524 6592178 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R