BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 20226758 · Received September 16, 2024

    Report

    Report Number
    2242352-2024-0001041
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Date of Event
    August 26, 2024
    Report Date
    October 3, 2024
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 08/30/2024. AN INVESTIGATION WAS CONDUCTED ON 09/11/2024. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WAS OBSERVED ON THE INTACT BTT. 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 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 # 3000412788 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 THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2 CO2 WAS OCCLUDED WHEN HOOKING UP TO THE BLUNT TIP TROCAR. THE HARVESTER ATTEMPTED TO "UNSTICK" THE VALVE BY INSERTING THE TIP OF A MOSQUITO INTO IT. THAT DID NOT WORK. THE CO2 WAS NOT OCCLUDED WHEN IT WAS HOOKED UP TO THE HEMOPRO 2 CANNULA. HARVESTERS HAD TO PULL A VASOVIEW ACCESSORY PACK OFF THE SHELF TO FINISH THE CASE. THERE WAS NO DELAY AND NO NEED TO INCREASE THE INCISION SIZE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1404090 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-4000 3000412788 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male UNKNOWN.