BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 21178586 · Received January 17, 2025

    Report

    Report Number
    2242352-2025-0000058
    Event Type
    Malfunction
    Date Received
    January 17, 2025
    Date of Event
    November 27, 2024
    Report Date
    April 8, 2025
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE # (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

    (B)(4). UPDATED SECTIONS: B4, D9, G3, G6, H2, H3, H6, H11. THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 02/19/2026. AN INVESTIGATION WAS CONDUCTED ON 04/17/2026. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND NO EVIDENCE OF BLOOD WAS OBSERVED. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE INTACT BTT. A 25 CC SYRINGE, FILLED WITH AIR WAS ATTACHED TO THE INFLATION PORT LINE ON THE BTT AND SQUEEZED THE SYRINGE TO INJECT AIR. THE BTT WAS ABLE TO BE INFLATED. A 25CC SYRINGE, FILLED WITH SALINE WAS ATTACHED TO THE CO2 LINE ON THE BTT AND SQUEEZED THE SYRINGE TO SPRAY THE SALINE WITH NO ISSUES. A 25CC SYRINGE, FILLED WITH SALINE WAS ATTACHED TO THE CO2 LINE ON THE BTT AND SQUEEZED THE SYRINGE TO SPRAY THE SALINE. THERE WAS NO BACKFLOW OBSERVED IN THE CO2 LINE. BASED ON THE RETURNED CONDITION OF THE DEVICE AS WELL AS THE EVALUATION RESULTS, THE REPORTED FAILURE "INFLATION PROBLEM" WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 0

    TW # (B)(4). THE LOT # 3000408507 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 EVENT.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2 (VH-4000) WAS DEFECTED, THE TROCAR WAS NOT WORKING AS IF IT WAS BLOCKED.

    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 (VH-4000) WAS DEFECTED, THE TROCAR WAS NOT WORKING AS IT WAS BLOCKED,CO2 NOT PASSING THROUGH THE DEVICE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM. THERE WAS A PROCEDURE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005510 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-4000 3000408507 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male