BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 15171051 · Received August 4, 2022

    Report

    Report Number
    2242352-2022-00682
    Event Type
    Malfunction
    Date Received
    August 4, 2022
    Date of Event
    July 15, 2022
    Report Date
    August 18, 2022
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE ID (B)(4).

    Additional Manufacturer Narrative · 0

    TRACKWISE ID # (B)(4). A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR LOTS 25163442, 251629764, AND 3000238055 THE LAST 3 LOTS SHIPPED TO THE ACCOUNT PRIOR TO THE EVENT/AWARE DATE. THERE WERE NO NCMRS, REWORK, OR DEVIATIONS DOCUMENTED FOR THE LAST 3 LOTS SHIPPED TO THE ACCOUNT. BASED ON THE DHR/LHR REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE BATCH MANUFACTURING PROCESS AND THE REPORTED FAILURE. THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 08/08/2022. AN INVESTIGATION WAS CONDUCTED ON 08/15/2022. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WAS OBSERVED ON THE BTT. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE BTT. A MECHANICAL EVALUATION WAS CONDUCTED. 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 AND SQUEEZED THE SYRINGE TO SPRAY THE SALINE. THERE WAS NO BACKFLOW OBSERVED IN THE CO2 LINE. BASED ON THE CONDITION OF THE DEVICE, THE REPORTED FAILURES "IMPROPER FLOW OR INFUSION" WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, USING VASOVIEW HEMOPRO 2. THE PA WAS BEGINNING THE HARVEST AND STARTING THE DISSECTION PHASE. THEY INSERTED THE TROCAR INTO THE INCISION AND ATTEMPTED TO START THE CO2 BUT THE TUNNEL WOULD NOT INSUFFLATE. THEY THOUGHT THE GAS TANK WAS EMPTY AND HAD THAT CHANGED OUT BUT THAT DIDN'T WORK. THEY ENDED UP ATTACHING THE CO2 TO THE DISTAL INSUFFLATION PORT WHICH DID DELIVER THE CO2. THEY OPENED A SECOND KIT FOR A NEW TROCAR AND CONTINUED WITH THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2433602 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male