BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 4092544 · Received June 26, 2014

    Report

    Report Number
    2242352-2014-00715
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 1, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVAL CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE LAST 3 LOTS SHIPPED TO THE ACCOUNT PRIOR TO THE AWARE DATE. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. AN INTERNAL CORRECTIVE ACTION HAS BEEN ISSUED FOR THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE CO2 ON THE BTT SHORT PORT ON THE VASO VIEW HEMOPRO CO2 WAS NOT GETTING THROUGH. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374614 VASO VIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-3000

    Patients

    Seq Age Sex Outcome Treatment
    1