BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 21806763 · Received April 9, 2025

    Report

    Report Number
    2242352-2025-0000424
    Event Type
    Malfunction
    Date Received
    April 9, 2025
    Date of Event
    March 17, 2025
    Report Date
    April 16, 2025
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (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

    TW (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION 03/21/2025. AN INVESTIGATION WAS CONDUCTED. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND 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 "IMPROPER FLOW OR INFUSION" WAS NOT CONFIRMED. THE LOT # 3000458336 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 AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW HEMOPRO 2, WHILE DOING A DISSECTION THE CUSTOMER RECEIVED A INSUFFLATION OCCLUSION ALARM ON THEIR INSUFFLATION DEVICE. CUSTOMER UNABLE TO RECTIFY THE ALARM AFTER ENSURING CONNECTIONS WERE TIGHT. THE CUSTOMER CHANGED THE EVH KITS AND THE NEW DEVICE WORKED WITHOUT ISSUE. NO HARM TO THE PATIENT. NO PROCEDURE DELAY.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416187 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-4000 3000458336

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female