BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 15833762 · Received November 21, 2022

    Report

    Report Number
    2242352-2022-00945
    Event Type
    Malfunction
    Date Received
    November 21, 2022
    Report Date
    December 5, 2022
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE ID (B)(4). THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 11/02/2022. AN INVESTIGATION WAS CONDUCTED ON 11/15/2022. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND NO EVIDENCE OF BLOOD WERE OBSERVED ON THE DEVICE. THE CANNULA WAS RETURNED WITH THE HANDLE IN TWO PARTS. NO OTHER VISUAL DEFECTS WERE OBSERVED ON THE DEVICE. A MECHANICAL EVALUATION WAS CONDUCTED. THE HANDLE WAS ABLE TO BE SNAPPED BACK TOGETHER TO ITS NORMAL STATE WITH NO PHYSICAL DIFFICULTIES. BASED ON THE RETURNED CONDITION OF THE DEVICE AS WELL AS THE INVESTIGATION RESULTS, THE REPORTED FAILURE "BREAK; HANDLE" WAS NOT CONFIRMED. THE LOT # 3000268642 HISTORY RECORD REVIEW WAS COMPLETED. THERE WERE NCMRS, REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED LOT NUMBER. A NOTIFICATION WAS RECEIVED FROM GXO THAT 2 STERILE LOADS CAME TO THEIR FACILITY WITH EXTERNAL DAMAGE. DURING THE INBOUND INSPECTION 2 OUT OF 500 UNITS FOR MATERIAL VH-4000 BATCH # 3000268642 AND 2 OUT OF 500 UNITS FOR MATERIAL # VH-4000, BATCH # 3000263853 WERE FOUND DAMAGED. BASED ON THE DHR/LHR REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE BATCH MANUFACTURING PROCESS AND THE REPORTED FAILURE.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE VASOVIEW HEMOPRO 2 WHITE PLASTIC PART OF THE CANNULA BROKE INTO TWO PIECES WHILE REMOVING IT FROM THE PACKAGING. FINISHED CASE USING NEW KIT. NO ADDED INCISIONS OR TIME. NO PATIENT HARM.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1796976 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2 3000268642 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNK.| UNKNOWN.