BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 21000722 · Received December 23, 2024

    Report

    Report Number
    2242352-2024-0001381
    Event Type
    Malfunction
    Date Received
    December 23, 2024
    Date of Event
    November 29, 2024
    Report Date
    March 19, 2025
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE ID#: (B)(4). THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

    Additional Manufacturer Narrative · 0

    TRACKWISE # (B)(4). UPDATED SECTION: B4, D9, G3, G6, H2, H3, H6, H11. THE LOT # 3000422645 HISTORY RECORD REVIEW WAS COMPLETED .THERE WERE NO NCMRS, REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED LOT NUMBER. BASED ON THE DHR/LHR REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE BATCH MANUFACTURING PROCESS AND THE REPORTED FAILURE. SPECIFIC ACTIONS FOR THE REPORTED FAILURE MODE ARE BEING MAINTAINED AND DOCUMENTED UNDER MAQUET'S CORRECTIVE AND PREVENTIVE ACTION (CAPA) SYSTEM.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT EVERYTHING WAS GOING WELL, AND THEY WERE NEAR THE END OF THE PROCESS OF CUTTING BRANCHES WHEN THEY SUDDENLY NOTICED THE VASOVIEW HEMOPRO 2 (VH-4000) C-RING HAD COME UNATTACHED ON ONE SIDE FROM THE ARMS THAT HOLD IT. THEY HAD JUST FINISHED DOING A LARGE, COMPLEX BRANCH BUNDLE. NOTHING COMPLETELY DETACHED OR FELL INTO THE TUNNEL. CASE WAS COMPLETED WITHOUT INCIDENT OR FURTHER DELAY BY OPENING A NEW HEMOPRO KIT. NO HARM OR ADDITIONAL FOLLOW UP TO THE PATIENT REQUIRED.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2616742 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-4000 3000422645

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female NO CONCOMITANT PRODUCTS.