BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 18453741 · Received January 5, 2024

    Report

    Report Number
    2242352-2024-00003
    Event Type
    Malfunction
    Date Received
    January 5, 2024
    Report Date
    February 7, 2024
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE#: (B)(4) UPDATED SECTIONS: B4, G4, G7, H2, H3, H6, H10 THE DEVICES WERE RETURNED TO THE FACTORY FOR EVALUATION ON (B)(6) 2023. AN INVESTIGATION WAS CONDUCTED ON (B)(6) 2024. DEVICES WERE RETURNED INSIDE THEIR RESPECTIVE PRODUCT PACKAGING. A VISUAL INSPECTION WAS CONDUCTED. NO SIGNS OF CLINICAL USE WAS OBSERVED. EACH PRODUCT TRAY WAS SEALED INSIDE EACH RESPECTIVE POUCH. THE JAWS OF THE 11 DEVICES WERE OBSERVED TO BE INTACT, WITH NO VISUAL DEFECTS OBSERVED. THERE WAS NO PEELING OF THE CLEAR SILICONE INSULATION ON BOTH THE HOT AND COLD JAWS ON ANY OF THE DEVICES JAWS. ONETRACK (B)(4) WAS RETURNED IN AN OPENED STATE. THERE WERE NO SIGNS OF CLINICAL USE AND NO EVIDENCE OF BLOOD WAS OBSERVED. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE HARVESTING DEVICE. THE HEATER WIRE WAS OBSERVED TO BE INTACT. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE CLEAR SILICONE INSULATION ON BOTH THE COLD AND HOT JAWS. NO PEELING OR DELAMINATION WAS OBSERVED. BASED ON THE RETURNED CONDITION OF THE DEVICES AND NO SPECIFIC FAILURE REPORTED, THERE WERE NO FAILURES OBSERVED. THE DHR SHOP FLOOR PAPERWORK WAS REVIEWED. THE VENDOR CERTIFIES THAT THIS DEVICE LOT CONFORMS TO ALL APPLICABLE PRODUCT SPECIFICATIONS. THE LOT # 3000347797 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.

    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.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED INSULATION TIP NOT ON JAWS IN BACK TO BACK CASES WITH THE SAME LOT NUMBER AND DECIDED TO BE PROACTIVE AND REMOVE THE 11 REMAINING VH-4000 VASOVIEW HEMOPRO 2 UNITS FROM THE SHELF. THESE ITEMS HAVE NOT BEEN USED. NO PATIENT INVOLVEMENT. RELATED TO 946322, 946331, 946333, 946335, 946337, 946843, 949848, 946857, 946864, 946273.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550165 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-4000 3000347797 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown N/A.