BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXT DRAINAGE SYSTEM III WITHOUT VENT CATH

    MDR report key: 2254223 · Received September 19, 2011

    Report

    Report Number
    1226348-2011-00355
    Event Type
    Injury
    Date Received
    September 19, 2011
    Manufacturer
    CODMAN AND SHURTLEFF - MEDOS
    Product Code
    JXG
    PMA / PMN Number
    K954021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THIS EVALUATION APPLIES TO COMPLAINTS # (B)(4) AS THE CUSTOMER WAS NOT ABLE TO INDICATE WHAT PRODUCTS WERE ASSOCIATED WITH EACH COMPLAINT. THE FOLLOWING OBSERVATIONS WERE NOTED DURING THE INVESTIGATIONS; ALL THREE EDS3 SYSTEMS STILL HAD SOME BIOLOGICAL DEBRIS IN THE LINES, DRIP CHAMBER AND COLLECTION BAG. SOME OF THE BIOLOGICAL DEBRIS WAS ALREADY DRY. ALL THREE EDS3 SYSTEMS WERE FLUSHED AND NO OBSTRUCTIONS AND/OR LEAKAGE WERE OBSERVED. ALL THREE EDS3 SYSTEMS WERE FILLED WITH PURIFIED WATER, MOUNTED TO AN I.V. POLE AND PROPERLY LEVELED. AS THE EDS3 SYSTEM WAS RAISED OR LOWERED FROM ITS LEVELED POSITION, IT WAS NOTED THAT THE PURIFIED WATER WAS SEEN MOVING - TO THE PATIENTS LINE IF THE SYSTEM WAS RAISED OR INTO THE DRIP CHAMBER IF THE SYSTEM WAS LOWERED. IF THE SYSTEM REMAINS LEVELED, NO MOVEMENT OF THE PURIFIED WATER WAS VERIFIED. THE ISSUE REPORTED BY THE CUSTOMER COULD BE CONFIRMED; HOWEVER, THE FOLLOWING IS STATED IN THE IFU (INSTRUCTIONS FOR USE) UNDER THE WARNINGS SECTION: INTRACRANIAL PRESSURE IS CONTROLLED BY THE HEIGHT OF THE DRIP CHAMBER RELATIVE TO THE PATIENT. IT IS IMPORTANT THAT NEITHER THE DRIP CHAMBER NOR THE PATIENT BE RAISED OR LOWERED ACCIDENTALLY. IF EITHER IS RAISED OR LOWERED, IT IS IMPERATIVE TO RE-LEVEL THE DRAINAGE SYSTEM. CLOSE THE PATIENT LINE STOPCOCK BEFORE TRANSPORTING THE PATIENT TO REDUCE THE RISK OF LIQUID REFLUXING TO THE PATIENT. THE HEIGHT OF THE DRIP CHAMBER OR THE POSITION OF THE PATIENT SHOULD ONLY BE CHANGED BY QUALIFIED PERSONNEL ON THE ORDERS OF A PHYSICIAN. MOVEMENT BY THE PATIENT AFTER POSITIONING OF THE DRIP CHAMBER MAY AFFECT THE PATIENTS ICP. IT APPEARS THAT THE EDS3 SYSTEM WAS NOT PROPERLY LEVELED AT SOME POINT CAUSING THE ISSUE REPORTED BY THE CUSTOMER. HOWEVER, THIS COULD NOT BE CONFIRMED. PRODUCTS LOT NUMBERS WERE NOT PROVIDED BY THE CUSTOMER; THEREFORE, THE LOT HISTORY RECORDS REVIEW FOR THESE RETURNED PRODUCTS COULD NOT BE PERFORMED. BASED ON THE RESULT S OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEEDS3 SYSTEM IS BACKING CSF INTO PATIENT. THE SYSTEM WAS CHANGED WHILE THE CATHETER REMAINED IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXT DRAINAGE SYSTEM III WITHOUT VENT CATH SHUNT, CENTRAL NERVOUS SYSTEM COMPS JXG CODMAN AND SHURTLEFF - MEDOS

    Patients

    Seq Age Sex Outcome Treatment
    1