BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 2062309 · Received March 18, 2011

    Report

    Report Number
    2242352-2011-00160
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 18, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A VISUAL INSPECTION REVEALED THAT THE C-RING WAS SPLIT IN HALF. THE OTHER HALF OF THE C-RING AND THE ENTIRE SCOPE WASH TUBING WERE RECEIVED SEPARATE. THERE WAS SOME EVIDENCE OF BLOOD. BASED UPON THE VISUAL OBSERVATIONS, THE REPORTED COMPLAINT FOR "C-RING SPLIT" WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO C-RING SPLIT IN HALF DURING THE PROCEDURE. 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 EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25026693

    Patients

    Seq Age Sex Outcome Treatment
    1 NA