BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 12137999 · Received July 8, 2021

    Report

    Report Number
    2242352-2021-00557
    Event Type
    Malfunction
    Date Received
    July 8, 2021
    Date of Event
    June 17, 2021
    Report Date
    January 26, 2022
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE # (B)(4). ANALYSIS OF PRODUCTION: (3331/213/67) THE DEVICE HISTORY RECORDS REVIEW CONCLUDED THAT 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 MANUFACTURING PROCESS AND THE REPORTED FAILURE MODE. HISTORICAL DATA ANALYSIS: (4109/213/67) THE REVIEW OF THE HISTORICAL DATA INDICATES THAT NO OTHER SIMILAR COMPLAINTS WAS REPORTED FOR THE SAME LOT NUMBER AND REPORTED FAILURE MODE. TREND ANALYSIS: (4110/213/67) THE OVERALL 24 MONTH PRODUCT COMPLAINT TREND DATA FOR THE PERIOD (B)(6) 2019 THROUGH (B)(6) 2021 WAS REVIEWED. THERE WERE NO TRIGGERS IDENTIFIED FOR THE REVIEW PERIOD. COMMUNICATION/INTERVIEWS: (4111/213/67) COMMUNICATION/INTERVIEWS WERE PERFORMED TO OBTAIN ALL POSSIBLE INFORMATION. DEVICE NOT RETURNED: (4114/67/213/3221) DESPITE REQUEST AND/ OR CUSTOMER INDICATED THAT THE DEVICE WOULD BE RETURNED; HOWEVER, NO DEVICE WAS RETURNED.

    Description of Event or Problem · 0

    ADDITIONAL COMPLAINT RECORD HAS BEEN CREATED DUE TO UNRELATED FAILURE MODE(S) TW ID (B)(4).

    Additional Manufacturer Narrative · 1

    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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    ADDITIONAL COMPLAINT RECORD HAS BEEN CREATED DUE TO UNRELATED FAILURE MODE (S) (B)(4). THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW HEMOPRO 2, THE CAUTERY BUTTON ITSELF ON THE DEVICE APPEARED TO COME LOOSE HALFWAY THROUGH THE CASE. THE CASE WAS FINISHED WITH SECOND DEVICE. POLYFUSE WAS NOT IN EFFECT NO PT WAS HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031502 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2 25157577 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown