BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 3810984 · Received March 23, 2014

    Report

    Report Number
    2242352-2014-00309
    Event Type
    Malfunction
    Date Received
    March 23, 2014
    Report Date
    February 25, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED SIGNS OF CLINICAL USAGE AND EVIDENCE OF BLOOD. A VISUAL INSPECTION DETERMINED THAT THE SHAFT TIP WAS DAMAGED AND BENT. WHILE WE WERE UNABLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE, THIS PROBLEM IS CONSISTENT WITH AN IMPROPER INSERTION OF THE TOOL INTO THE CANNULA. BASED UPON THE RECEIVED CONDITION OF THE DEVICE, THE REPORTED COMPLAINT WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NON-CONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE STERILE PACKAGE OF A HEMOPRO 2 WAS OPENED ON THE SURGICAL FIELD AND IT WAS OBSERVED THAT IT WAS BROKEN. 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
    171291 VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-4000 25090239

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR