BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMBIOS GOPUMP

    MDR report key: 3111303 · Received May 9, 2013

    Report

    Report Number
    3005203102-2013-00004
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 9, 2013
    Manufacturer
    SYMBIOS MEDICAL PRODUCTS
    Product Code
    MEB
    PMA / PMN Number
    K072921
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MDR SUBMITTED UNDER 21 CFR 803.53; RECALL ACTIVITIES CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    PROCEDURE ABDOMINOPLASTY, BREAST LIFT; 12 CC MARCAINE 0.5% + EPI DELIVERED VIA EACH CATHETER PRIOR TO ATTACHING PUMP, WHICH CONTAINED 2 X 150 ML OF 0.5% MARCAINE. CATHETERS PLACED IN RECTUS SHEATH. PT COLLAPSED AND CODED WHILE "WALKING OUT THE DOOR". SHOWED SIGNED OF NEUROLOGICAL AGITATION, MULTIPLE SEIZURES AND WENT INTO CARDIAC ARREST. ONE SIDE OF PUMP WAS NOTED TO BE EMPTY; DR OPENED WOUND SITE AND SUCTION FLUID FROM WOUND. PT ADMITTED TO ICU, INTUBATED OVERNIGHT, REPORTED TO BE AWAKE, ALERT NEXT MORNING. PT EXTUBATED (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204916 SYMBIOS GOPUMP ELASTOMERIC INFUSION PUMP MEB SYMBIOS MEDICAL PRODUCTS 510076 12-100758-1410-0621

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R