BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 19018930 · Received April 2, 2024

    Report

    Report Number
    2242352-2024-00312
    Event Type
    Malfunction
    Date Received
    April 2, 2024
    Date of Event
    March 12, 2024
    Report Date
    April 30, 2024
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    TRACKWISE#: (B)(4). UPDATED SECTIONS: B4, D9, G3, G6, H2, H3, H6, H10 . THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 04/04/2024. A PHOTOGRAPH WAS PROVIDED BY THE ACCOUNT. A PHOTOGRAPHIC EVALUATION WAS CONDUCTED. PRODUCT INFORMATION WAS OBSERVED IN ONE PHOTOGRAPH. SIGNS OF CLINICAL USE AND NO EVIDENCE OF BLOOD WAS OBSERVED ON THE BTT. THE INSUFFLATION TUBE WAS OBSERVED TO BE DISCONNECTED FROM THE BODY OF THE BTT. NO OTHER VISUAL DEFECTS WERE OBSERVED IN THE PHOTOGRAPH. A VISUAL INSPECTION WAS CONDUCTED ON 04/10/2024. SIGNS OF CLINICAL USE AND NO EVIDENCE OF BLOOD WAS OBSERVED. THE INSUFFLATION TUBE WAS OBSERVED TO BE DETACHED FROM THE INTACT BODY OF THE BTT. NO OTHER VISUAL DEFECTS WERE OBSERVED. BASED ON THE RETURNED CONDITION OF THE DEVICE AS WELL AS THE EVALUATION RESULTS, THE REPORTED FAILURE "CONNECTION ISSUE" WAS CONFIRMED. SPECIFIC ACTIONS FOR THE REPORTED FAILURE MODE ARE BEING MAINTAINED AND DOCUMENTED UNDER MAQUET'S CORRECTIVE AND PREVENTIVE ACTION (CAPA) SYSTEM. THE LOT # 3000359541 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 FAILURE.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2 CO2 SUPPLY LINE DEFECTIVE. THE CO2 DISCHARGE HAS DETACHED FROM THE BTT PORT. PER PHOTO PROVIDED BY THE COMPLAINANT, THE CO2 LINE IS NOT CONNECTED TO THE BTT PORT. COMPLETED WITH NEW DEVICE. THERE WAS A DELAY. NO HARM TO PATIENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1518724 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-4000 3000359541 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male UNKNOWN.