BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNAL DRAINAGE SET

    MDR report key: 144293 · Received January 16, 1998

    Report

    Report Number
    9612007-1998-00004
    Event Type
    Injury
    Date Received
    January 16, 1998
    Date of Event
    December 4, 1997
    Report Date
    December 18, 1997
    Manufacturer
    ELEKTA IMPLANTS S.A.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING ANALYSIS HAS BEEN PERFORMED ON THE RETURNED PRODUCT: VISUAL EXAMINATION: AN EXTERNAL DRAINAGE SET WITHOUT THE ORIGINAL PACKAGING WAS RECEIVED. THE SAPHIRE BALL WAS "STUCK" IN OPEN POSITION IN THE MIDDLE OF THE CHECK VALVE ASSEMBLY. YELLOWISH STAINS WERE OBSERVED ON THE OUTSIDE OF THE FOUR-WAY STOPCOCK. THIS STOPCOCK WAS DAMAGED BY MECHANICAL ACTION WITH AN INSTRUMENT. THE INSIDE OF THE SET WAS RETURNED IN A CLEAN CONDITION (NO SIGN OF PRODUCT BEING USED). FUNCTIONAL TESTING: BEFORE DECONTAMINATION, THE SET WAS FUNCTIONALLY TESTED FOR PATENCY, AND NO OBSTRUCTION WAS NOTED. AS SOON AS THE BALL WAS IN CONTACT WITH WATER IT BECAME FREE AND ROLLED IN NORMAL POSITION. STOPCOCK IS FUNCTIONAL. CONCLUSION: THE SET AS RECEIVED WAS FUNCTIONAL. THE AVAILABLE INFO DO NOT ALLOW US TO DETERMINE THE EXACT CAUSE OF THE PROBLEM.

    Description of Event or Problem · 1

    REPORT REC'D FROM THE HOSP INDICATED THAT A PEDIATRIC PT WITH AN EXTERNAL DRAINAGE SET HAD BEEN DRAINING APPROXIMATELY 50CC OF CSF EVERY 2 HRS; THE SYSTEM HAS BEEN IN USE FOR 2 TO 4 DAYS; THEN THE PT BECAME LETHARGIC AND SYMPTOMATIC FOR INCREASED INTRACRANIAL PRESSURE WHEN DRAINAGE SUDDENLY STOPPED. CSF WAS MANUALLY DRAWN FROM THE SHUNT RESERVOIR TO RELIEVE PRESSURE AND THE SYSTEM WAS REPLACED. CSF BEGAN TO FLOW EASILY AT THE SAME RATE AS PREVIOUSLY. THE INITIAL REPORTER SUSPECTS A DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTERNAL DRAINAGE SET Implant EXTERNAL DRAINAGE SET JXG ELEKTA IMPLANTS S.A. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention