BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 17626116 · Received August 25, 2023

    Report

    Report Number
    2242352-2023-00717
    Event Type
    Malfunction
    Date Received
    August 25, 2023
    Date of Event
    August 7, 2023
    Report Date
    September 19, 2023
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE # (B)(4). THE LOT # 3000281080 HISTORY RECORD REVIEW WAS COMPLETED. THERE WERE TWO (02) 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. H3 OTHER TEXT : DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    (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

    RELATED TO: 870244. THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2 PRODUCED POOR VISIBILITY. ADJUSTMENTS MADE TO INSUFFLATOR WITH NO CHANGE OF VISIBILITY. DEVICE WAS UNABLE TO USE. INCREASED THE LENGTH OF TIME FOR THAT PORTION OF THE PROCEDURE. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2083809 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-4000 3000281080 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown