BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 20568330 · Received October 30, 2024

    Report

    Report Number
    2242352-2024-0001196
    Event Type
    Malfunction
    Date Received
    October 30, 2024
    Date of Event
    October 10, 2024
    Report Date
    November 20, 2024
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TW 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

    TRACKWISE#: (B)(4). UPDATED SECTIONS: B4, G3, G6, H2, H3, H6, H11. CORRECTED SECTIONS: H6--MEDICAL DEVICE ¿ PROBLEM CODE CORRECTED FROM "2183" TO "2900 AND 2954" THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 10/16/2024. AN INVESTIGATION WAS CONDUCTED ON 11/05/2024. 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. THE BTT WAS ABLE TO BE INFLATED. NO VISUAL DEFECTS WERE OBSERVED ON THE SILICONE BTT. A 5CC SYRINGE FILLED WITH SALINE WAS ATTACHED TO THE CO2 LINE ON THE BTT WITH NO PHYSICAL OR VISUAL DIFFICULTIES OBSERVED 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 FAILURES "CONNECTION PROBLEM" AND "IMPROPER FLOW OR INFUSION" WERE NOT CONFIRMED. THE LOT # 3000422800 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.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2 WAS HAVING ISSUES WITH INSUFFLATION INTO THE TUNNEL. THE INSUFFLATION TUBING'S MALE END WAS NOT PUSHING THE BTT FEMALE VALVE DOWN. SO INSUFFLATION WAS NOT GETTING INTO THE TUNNEL CORRECTLY. THEY STRUGGLED AND WERE ABLE TO GET THE VEIN OUT WITH NO ISSUES TO PATIENT OR THE VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020574 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-4000 3000422800 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.