BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 19425130 · Received May 30, 2024

    Report

    Report Number
    2242352-2024-00620
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    May 3, 2024
    Report Date
    August 1, 2024
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE#: (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 05/22/2024. AN INVESTIGATION WAS CONDUCTED ON 05/28/2024. 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. A 25 CC SYRINGE, FILLED WITH AIR WAS ATTACHED TO THE INFLATION PORT LINE ON THE BTT AND SQUEEZED THE SYRINGE TO INJECT AIR. THE BTT WAS ABLE TO BE INFLATED. A 25CC SYRINGE, FILLED WITH SALINE WAS ATTACHED TO THE CO2 LINE ON THE BTT AND SQUEEZED THE SYRINGE TO SPRAY THE SALINE WITH NO ISSUES. A 25CC 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 "INFLATION PROBLEM" WAS NOT CONFIRMED. SPECIFIC ACTIONS FOR THE REPORTED FAILURE MODE ARE BEING MAINTAINED AND DOCUMENTED UNDER MAQUET'S CORRECTIVE AND PREVENTIVE ACTION (CAPA) SYSTEM. THE LOT # 3000380314 HISTORY RECORD REVIEW WAS COMPLETED. THERE WAS A NCMR, 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. E1 EVENT SITE NAME DUE TO CHARACTER RESTRICTIONS (B)(6) HOSPITAL AND HLT CTR.

    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 BALLOON IN THE BTT DIDN'T MAINTAIN ITS SEAL DURING INSUFFLATION AND LED TO THE TUNNEL COLLAPSING. HARVESTER TRIED TO TROUBLESHOOT THE ISSUE BY INFLATING THE BTT AGAIN BUT THE BALLOON WOULD NOT HOLD A SEAL. A NEW KIT WAS OPENED TO CONTINUE THE PROCEDURE. THERE WAS LITTLE IF ANY PROCEDURAL DELAY. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1422355 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-4000 3000380314

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.