BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXT DRAINAGE SYSTEM III WITHOUT VENT CATH

    MDR report key: 3894946 · Received June 25, 2014

    Report

    Report Number
    1226348-2014-11760
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 8, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    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

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

    Additional Manufacturer Narrative · 1

    AN EDS III WAS RETURNED FOR EVALUATION. THE INVESTIGATION OF THE EDS III DID NOT CONFIRM THE PROBLEM REPORTED BY THE CUSTOMER. THE LOT NUMBER IS CRBBZW, PRODUCT CODE 82-1731. THE EDS III WAS VISUALLY INSPECTED AND TRACES OF BIOLOGICAL DEBRIS WERE NOTED ON THE FILTER IN THE TOP OF DRIP CHAMBER, AT THE BOTTOM OF THE DRIP CHAMBER, AND IN THE COLLECTION BAG. THE EDS III WAS SET UP AS PER IFU. THE DRIP CHAMBER STOP COCK WAS TURNED TO THE OFF POSITION SO THAT THE PURIFIED WATER STAYED IN THE DRIP CHAMBER. 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 A BIT SLOWER THAN NORMAL, AND EMPTED INTO THE COLLECTION BAG. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 24TH JANUARY 2014. THE ROOT CAUSE OF THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED, THE DRIP CHAMBER FLOWED INTO THE COLLECTION BAG SLIGHTLY SLOWER THAN NORMAL, THIS COULD BE DUE TO THE FILTER IN THE DRIP CHAMBER COMING INTO CONTACT WITH BIOLOGICAL DEBRIS. AS NOTED IN THE IFU : CAUTION: CLOSE THE CLAMP BELOW THE ATMOSPHERIC VENT TO PREVENT WETTING THE VENT WHEN THE BAG IS LAID DOWN, SUCH AS DURING PATIENT TRANSPORT. IF THE VENT BECOMES WET, IT MAY PREVENT THE FLOW OF CSF INTO THE BAG. ONCE THE SYSTEM IS SET UP ON AN IV POLE OR OTHER SUPPORT, OPEN THE CLAMP BELOW THE VENT. NO CORRECTIVE ACTION IS NEEDED BASED ON THE RESULTS OF THE EVALUATION. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    PATIENT THAT HAS UNDERGONE EXTERNAL DRAINAGE DUE TO HYDROCEPHALUS AFTER THE SURGERY. WHEN THE PATIENT WAS USING THE EXTERNAL DRAINAGE SYSTEM BY CODMAN, THERE WAS NOT POSSIBLE TO GET THE CSF FROM THE CYLINDER TO THE EXTERNAL DRAINAGE BAG. (DURING USE ON PATIENT). EVENT OR PRODUCT PROBLEM OUTCOME: REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. DESCRIBE THE 'DAMAGE' OR 'OTHER' OUTCOME: NEW EDS WAS USED FOR THE PATIENT.

    Description of Event or Problem · 1

    PLEASE ALSO SEE COMPLAINT (B)(4). 6/27/2014 AS THIS COMPLAINT WAS RECEIVED THE AFFILIATE STATED THAT 3 OTHER INCIDENTS OCCURRED. THE ORIGINAL REPORTING AFFILIATE IS NO LONGER WITH THE COMPANY AND NO ADDITIONAL INFORMATION CAN BE OBTAINED REGARDING THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370705 EXT DRAINAGE SYSTEM III WITHOUT VENT CATH SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF CRBBZW

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention