BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 20696557 · Received November 15, 2024

    Report

    Report Number
    2242352-2024-0001252
    Event Type
    Malfunction
    Date Received
    November 15, 2024
    Date of Event
    October 21, 2024
    Report Date
    February 27, 2025
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TW#: (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 11/26/2024. AN INVESTIGATION WAS CONDUCTED ON 01/07/2025. A VISUAL INSPECTION WAS CONDUCTED. THE HARVESTING DEVICE, CANNULA AND THE BTT WAS RETURNED FOR EVALUATION. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WAS OBSERVED. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE INTACT HARVESTING DEVICE OR THE INTACT CANNULA. THE BTT WAS ABLE TO BE INFLATED. NO VISUAL DEFECTS WERE OBSERVED ON THE SILICONE BTT. THE CO2 TUBING OF THE BTT WAS OBSERVED TO BE DETACHED FROM THE BODY OF THE BTT. AN ENGINEER EVALUATION WAS CONDUCTED. THE BTT BODY AND THE INSUFFLATION TUBING WERE INSPECTED VISUALLY UNDER MAGNIFICATION. AFTER INSPECTION OF THE COMPLAINT DEVICE IT WAS IDENTIFIED THAT THERE WAS VISIBLE RESIDUAL ADHESIVE ON THE BTT BODY AND ON THE INSUFFLATION TUBING. HOWEVER, THERE WAS INSUFFICIENT ADHESIVE TO SECURE THE INSUFFLATION TUBING TO THE BTT PORT. BASED ON THE RETURNED CONDITION OF THE DEVICE AS WELL AS THE EVALUATION RESULTS, THE REPORTED FAILURE "BREAK" WAS CONFIRMED. THE LOT#: 3000425177 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 FAILURES. SPECIFIC ACTIONS FOR THE REPORTED FAILURE MODE ARE BEING MAINTAINED AND DOCUMENTED UNDER MAQUET'S CORRECTIVE AND PREVENTIVE ACTION (CAPA) SYSTEM.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2 CO2 TUBING TO THE BTT CAME OFF WHILE HOOKING UP THE BTT THE CO2. THIS HAPPENED AT THE VERY BEGINNING OF THE CASE WHEN THEY TOUCHED THE BTT THE FIRST TIME. CASE WAS COMPLETED BY OPENING AN ACCESSORY KIT. NO CASES DELAY BEYOND OPENING A NEW ACCESSORY KIT. NO PATIENT INVOLVEMENT OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1144814 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-4000 3000425177 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown