BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 2042352 · Received February 15, 2011

    Report

    Report Number
    2242352-2011-00142
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 15, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A VISUAL INSPECTION REVEALED THAT THE TOOL WAS RECEIVED INSIDE THE CANNULA. THE CANNULA TIP HAD MELTED. THE SILICONE JAWS HAD MELTED AS WELL AND COULD NOT BE REMOVED, OPENED, OR CLOSED. THERE WAS SOME EVIDENCE OF BLOOD. RESISTANCE MEASUREMENTS WERE FOUND TO BE OUT OF SPECIFICATION. A PRE-CAUTERY TEST WAS PERFORMED ON THE DEVICE WITH A REFERENCE POWER SUPPLY AND EXTENSION CABLE. THE DEVICE DID NOT PASS THE PRE-CAUTERY TEST, IT SELF-ACTIVATED. BASED UPON THIS, THE REPORTED FAILURE "SELF-ACTIVATED" IS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MADE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VH-3000 HEMOPRO SELF ACTIVATED WHEN IT WAS PLUGGED IN. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL 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 SYSTM GEI MAQUET CARDIOVASCULAR, LLC. VH-3000 25026753

    Patients

    Seq Age Sex Outcome Treatment
    1 NA