BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXT DRAINAGE SYSTEM III WITHOUT VENT CATH

    MDR report key: 4821485 · Received June 5, 2015

    Report

    Report Number
    1226348-2015-10325
    Event Type
    Injury
    Date Received
    June 5, 2015
    Date of Event
    May 13, 2015
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    PK954021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THE EDS III WAS VISUALLY INSPECTED, IT WAS ALSO NOTED THAT BIOLOGICAL DEBRIS HAS COME INTO CONTACT WITH THE FILTER IN THE DRIP CHAMBER. THE EDS III WAS SET UP AS PER IFU. THE DRIP CHAMBER STOP COCK WAS TURNED TO THE OFF POSITION. THE DRIP CHAMBER WAS THEN FILLED UP TO THE 20ML MARK WITH PURIFIED WATER. THE SYSTEM STOPCOCK WAS THEN CLOSED. THE DRIP CHAMBER STOPCOCK WAS OPENED; THE PURIFIED WATER FLOWED, AND EMPTIED INTO THE COLLECTION BAG. REVIEW OF THE HISTORY DEVICE RECORDS WAS NOT POSSIBLE AS THE LOT NUMBER WAS UNKNOWN. THE ROOT CAUSE OF THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED AS THE PURIFIED WATER FROM THE DRIP CHAMBER FLOWED INTO THE COLLECTION BAG. A CAPA HAS NOW BEEN OPEN AND IS ADDRESSING THIS ISSUE. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    EXTERNAL VENTRICULAR DRAIN IN SITU. NURSE CALLED THE PRODUCT SPECIALIST TO REPORT TROUBLE IN DRAINING CSF FROM THE CHAMBER INTO THE 700ML DRAINAGE BAG. THE PRODUCT SPECIALIST PERFORMED TROUBLESHOOTING BUT THE CSF CONTINUED TO DRAIN VERY SLOWLY, TAKING ABOUT 10 MINUTES TO DRAIN (WHEN IT NORMALLY ONLY TAKES ABOUT 30 SECONDS). PATIENT WAS NOTED TO HAVE GRAM POSITIVE INFECTION IN CSF. PATIENT WAS FINE. NO ADVERSE EVENT. REP HAS ASKED FOR THE HOSPITAL TO KEEP THE PRODUCT AND WILL ADVISE IF IT WILL BE AVAILABLE FOR INVESTIGATION. ON (B)(6) 2015: DID THIS EVENT OCCUR INTRA-OPERATIVELY? NO THE EVENT HAPPENED THE DAY AFTER THE EVD WAS INSERTED. WAS THERE A DELAY IN SURGERY OVER 30 MINUTES? NO NOT IN SURGERY-BUT ON THE WARD WHEN THE NURSES WERE DRAINING THE BURETTE INTO THE DRAINAGE BAG. WHAT ACTIONS WERE TAKEN AS A RESULT OF THIS INCIDENT? THE WHOLE SYSTEM HAD TO BE CHANGED. IS THERE A SERIAL OR LOT NUMBER YOU CAN PROVIDE? THE CUSTOMER IS UNABLE TO PROVIDE A LOT NUMBER. IT IS ANTICIPATED THAT THE DEVICE WILL BE AVAILABLE FOR EVALUATION AND ARE CURRENTLY AWAITING CONFIRMATION THAT THE DEVICE HAS BEEN RETRIEVED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364394 EXT DRAINAGE SYSTEM III WITHOUT VENT CATH SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention