BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 14744418 · Received June 20, 2022

    Report

    Report Number
    2242352-2022-00540
    Event Type
    Malfunction
    Date Received
    June 20, 2022
    Date of Event
    May 4, 2022
    Report Date
    June 28, 2022
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE 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 ID # (B)(4). THE LOT # 25163182 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. THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 06/07/2022. AN INVESTIGATION WAS CONDUCTED ON 06/09/2022. 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 VASOVIEW HEMOPRO 2. BTT PORT WAS NOT PROVIDING INSUFFLATION. THERE WAS THERE NO LEAK AT THE BTT OR WITHIN THE TUNNEL. THEY TRIED TO TROUBLESHOOT THE ISSUE BUT COULDN'T RESOLVE THE INSUFFLATION PROBLEM. THEY OPENED A NEW BTT PORT AND IT WORKED PROPERLY. A NEW DEVICE WAS OPENED AND COMPLETED PROCEDURE FINE.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE VASOVIEW HEMOPRO 2. BTT PORT WAS NOT PROVIDING INSUFFLATION. THERE WAS THERE NO LEAK AT THE BTT OR WITHIN THE TUNNEL. THEY TRIED TO TROUBLESHOOT THE ISSUE BUT COULDN'T RESOLVE THE INSUFFLATION PROBLEM. THEY OPENED A NEW BTT PORT AND IT WORKED PROPERLY. A NEW DEVICE WAS OPENED AND COMPLETED PROCEDURE FINE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1135688 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2 25163182 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CABG