BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO

    MDR report key: 18784225 · Received February 26, 2024

    Report

    Report Number
    2242352-2024-00148
    Event Type
    Malfunction
    Date Received
    February 26, 2024
    Date of Event
    February 2, 2024
    Report Date
    March 22, 2024
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567701250
    PMA / PMN Number
    K153194
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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, H10. THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 02/07/24. AN INVESTIGATION WAS CONDUCTED ON 02/08/2024. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD AND CHARRED MATERIAL WERE OBSERVED. THE CANNULA, C-RING, AND HARVESTING DEVICE WERE OBSERVED TO BE INTACT WITH NO VISUAL DEFECTS. NO VISUAL DEFECTS WERE OBSERVED ON THE BTT. A MECHANICAL EVALUATION WAS CONDUCTED. THE BTT WAS ABLE TO BE INFLATED. NO VISUAL OR PHYSICAL DEFECTS WERE OBSERVED ON THE SILICONE OF THE BTT. A 5CC SYRINGE FILLED WITH SALINE WAS ATTACHED TO THE CO2 LINE ON THE BTT. THE SYRINGE WAS DEPRESSED TO SPRAY THE SALINE. THERE WAS NO BACKFLOW OBSERVED IN THE CO2 LINE. BASED ON THE RETURNED CONDITION OF THE DEVICE AND INVESTIGATION RESULTS, THE REPORTED FAILURE "IMPROPER FLOW OR INFUSION" WAS NOT CONFIRMED. THE LOT # 3000365391 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 VESSEL HARVESTING PROCEDURE, VASOVIEWHEMPRO VH-3500 HAD A 'BAD TROCAR'. DESPITE VETERAN HARVESTER'S BEST EFFORTS IT KEPT LEAKING CO2. LEAK WAS HAPPENING AT THE BTT PORT. CONNECTION WAS SEEMINGLY FINE. A NEW DEVICE WAS OPENED AND CASE COMPLETED PERFECTLY FINE. THERE WAS A PROCEDURAL DELAY TO IDENTIFY PROBLEM AND GET A NEW KIT TO COMPLETE CASE. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1539072 VASOVIEW HEMOPRO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-3500 3000365391 00607567701250

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.