BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC

    MDR report key: 3010738 · Received March 12, 2013

    Report

    Report Number
    MW5029385
    Event Type
    Other
    Date Received
    March 12, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 12, 2013
    Manufacturer
    MEDTRONIC
    Product Code
    JXG
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UPON ROUNDING AND ASSESSMENT OF PT, RN NOTED CLEAR DRAINAGE IN EVD CONTAINER VENTRICULAR DRAIN AND THEN NOTED FLUIDS IV DILANTIN WERE INFUSING THROUGH THE EVD TO THE PT. FLUIDS WERE STOPPED AND NEUROSURGEON IMMEDIATELY NOTIFIED. DRAIN WAS FLUSHED PER PHYSICIAN; NO CHANGE IN NEURO STATUS NOTED. RN STATED HE DID NOT TRACE LINE AND INADVERTENTLY CONNECTED IV DILANTIN INFUSION TO THE STOPCOCK ON THE EVD TUBING. THE EVD TUBING DID HAVE THE BLUE LINE AND WAS LABELED APPROPRIATELY. INTERIM MEASURE INITIATED: PORTS ON EVD TUBING WERE TAPED OFF; LOOKING INTO PURCHASING MEDTRONIC DELTA VALVES TO PLACE ON PORTS THAT WOULD ALLOW ASPIRATION BUT NOT INJECTION. DATES OF USE: (B)(6) 2013 (10 DAYS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104444 MEDTRONIC EXACTA EXTERNAL DRAINAGE AND MONITORING SYSTEM JXG MEDTRONIC 11773881

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR