BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 3150021 · Received June 3, 2013

    Report

    Report Number
    3008355164-2013-00138
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 5, 2013
    Report Date
    May 6, 2013
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH BOWEL DYSFUNCTION WAS ABOUT TO UNDERGO AN ABDOMINAL CT SCAN; THEREFORE, A RETENTION INSPECTION WAS DONE PRIOR TO TRANSPORT FROM THE ROOM. THIS RETENTION INSPECTION THAT WAS DONE THROUGH THE EDI CATHETER DID NOT PRODUCE ANY LIQUID WHICH WAS INTERPRETED BY STAFF TO MEAN THAT THERE WAS NO LIQUID IN THE STOMACH. THEREAFTER THE FEEDING LUMEN OF THE EDI CATHETER WAS CLOSED AND THE PATIENT WAS TRANSPORTED. HOWEVER, 3 HOURS LATER IT WAS NOTICED THAT GASTRIC FLUID WAS FLOWING THROUGH THE PATIENT'S MOUTH. THE FEEDING LUMEN WAS OPENED UP AND A BAG WAS CONNECTED TO IT FOR PASSIVE DRAINAGE THAT RESULTED IN DRAINAGE OF 1000 ML OF GASTRIC FLUID. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242397 SERVO-I CBK MAQUET CRITICAL CARE AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI