BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    MDR report key: 2153217 · Received June 17, 2011

    Report

    Report Number
    2242352-2011-00645
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THERE WERE NO NON-CONFORMITIES WITH THE CANNULA. THERE WAS SOME EVIDENCE OF BLOOD. A FUNCTIONAL FLOW TEST WAS PERFORMED AND FLUID PASSED THROUGH THE INSUFFLATION TUBING. BASED UPON THIS, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NON-CONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO 2 COULD NOT MAINTAIN THE TUNNEL BECAUSE THERE WAS NO INSUFFLATION. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO 2 EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC. VH-4000 25033709

    Patients

    Seq Age Sex Outcome Treatment
    1 NA