BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 15332286 · Received August 31, 2022

    Report

    Report Number
    2242352-2022-00742
    Event Type
    Malfunction
    Date Received
    August 31, 2022
    Date of Event
    August 10, 2022
    Report Date
    November 11, 2022
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE ID (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR LOTS 3000262457, 3000244416, AND 25163320 THE LAST 3 LOTS SHIPPED TO THE ACCOUNT PRIOR TO THE EVENT/AWARE DATE. FOR THE TWO LOT NUMBERS, 3000262457, 3000244416. THERE WERE NO NCMRS, REWORK, OR DEVIATIONS DOCUMENTED FOR THE LAST 2 LOTS SHIPPED TO THE ACCOUNT. BASED ON THE DHR/LHR REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE BATCH MANUFACTURING PROCESS AND THE REPORTED FAILURE. THE LOT # 25163320 HISTORY RECORD REVIEW WAS COMPLETED. THERE WERE NCMRS , REWORK, OR DEVIATIONS DOCUMENTED FOR THE LOT NUMBER. [NCMR #17451-A NOTIFICATION WAS RECEIVED FROM GXO THAT SL# 0000001921 CAME INTO THEIR FACILITY WITHOUT A PACKING SLIP. PER PROCEDURE DOP10144 REV M, GXO SHOULD VERIFY THE SHIPMENT-PACKING LIST AND ACCOUNT FOR DUNNAGE FOR EVERY SHIPMENT. ALTHOUGH, GXO DID NOT HAVE THE PROPER DOCUMENTATION THEY DID RECEIVE THE MATERIAL INTO THEIR SYSTEM ]. BASED ON THE DHR/LHR REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE BATCH MANUFACTURING PROCESS AND THE REPORTED FAILURE. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE THE VASOVIEW HEMOPRO 2 BALLOON CUFF ON VASOVEIW HEMOPRO 2 HAD BURST UPON INFLATION AND THEY HAD TO OPEN ANOTHER KIT THIS WAS AT THE START OF THE CASE UPON INITIAL INSERTION.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2588002 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNKNOWN.