BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 3080010 · Received April 24, 2013

    Report

    Report Number
    2242352-2013-00407
    Event Type
    Injury
    Date Received
    April 24, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DSY
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVAL. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT AN EXCEL SOFT VASCULAR GRAFT WAS IMPLANTED INTO A PT AND CRP BEGAN TO GROW POST SURGERY. THE PT WAS RE-OPENED AND THE INFECTION AROUND THE GRAFT WAS NOT SEEN, BUT C-REACTIVE PROTEIN CONTINUED TO GROW. DUE TO HIGH CRP LEVELS, THE HOSPITAL SUSPECTED GRAFT INFECTION; HOWEVER, THIS WAS NOT THE CAUSE. AFTER THE THIRD LUNG EXAM, IT WAS DETERMINED THAT THE PT HAD PNEUMONIA. NO TREATMENT OF SUSPECTED GRAFT INFECTION WAS MADE. PT REACTED POSITIVELY TO THERAPY AND TREATMENT FOR PNEUMONIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176983 ASKU VASCULAR GRAFT DSY MAQUET CARDIOVASCULAR, LLC ASKU NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other