BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 21361069 · Received February 11, 2025

    Report

    Report Number
    2242352-2025-0000138
    Event Type
    Malfunction
    Date Received
    February 11, 2025
    Date of Event
    January 10, 2025
    Report Date
    May 9, 2025
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE - (B)(4). UPDATED SECTION - B4, D9, G3, G6, H2, H3, H6, H11. THE LOT #3000436459 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.

    Additional Manufacturer Narrative · 0

    TW # (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.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW HEMOPRO 2 (VH-4000), WHEN LIGATING BRANCHES DURING A SVG HARVEST THE HEMOPRO 2 STOPPED WORKING AFTER 2 BEEPS OF THE GENERATOR. THE HARVESTER PAUSED FOR 30 SECONDS AND ATTEMPTED BRANCH LIGATION AGAIN AND THE ISSUE PERSISTED. POWER SUPPLY SETTING AT 3. THERE WAS NO DELAY. THERE WAS NO PATIENT HARM. DEVICE IS REMOVED FROM SERVICE AND A NEW DEVICE WAS OPENED AND WORKED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846841 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-4000 3000436459 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male NO.