BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXT DRAINAGE SYSTEM III WITHOUT VENT CATH

    MDR report key: 3952854 · Received July 23, 2014

    Report

    Report Number
    1226348-2014-11839
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    July 7, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK954021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EDS III WAS VISUALLY INSPECTED AND TRACES OF BIOLOGICAL DEBRIS WERE NOTED ON THE FILTER IN THE TOP OF DRIP CHAMBER. THE EDS III WAS SET UP AS PER IFU. THE DRIP CHAMBER STOP COCK WAS TURNED TO THE OFF POSITION. PURIFIED WATER FLOWED INTO 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 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 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. TRENDS ARE BEING MONITORED WITH (B)(4). AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED: ON JULY 24, 2014, THE SALES REP. INFORMED THAT THE CUSTOMER CONFIRMED THAT THE SHUNT MENTIONED IN THE MEDWATCH FORM WAS A NON-CODMAN SHUNT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT: "OVER THE LAST 3-4 MONTHS, WE HAVE HAD 4 EQUIPMENT MALFUNCTIONS WITH OUR CODMAN EXTERNAL VENTRICULAR DRAIN COLLECTION DEVICES. THE BURTROLL DOES NOT CORRECTLY DRAIN INTO THE DRAINAGE BAG, REQUIRING THE SYSTEM TO BE CHANGED OUT BY THE NEUROSURGEON. THE EXCHANGE/MALFUNCTION CAN CAUSE CHANGES IN INTRACRANIAL PRESSURE AND INCREASE RISK OF INFECTION". ALSO SEE COMPLAINTS # (B)(4). MEDWATCH RECEIVED FROM THE CUSTOMER INFORMED THAT: "FLUID IN BURETROL WILL NOT DRAIN EASILY INTO COLLECTION BAG. REQUIRED LOTS OF MANIPULATION TO GET BURETROL TO DRAIN FLUID ALREADY COLLECTED IN IT TO THE COLLECTION BAG BELOW IT. ADDITIONAL INFORMATION: "PATIENT WAS ADMITTED FOR RECURRENT SEIZURES CAUSED BY SHUNT MALFUNCTION & INFECTION. EVD PLACED IN OR ALONG WITH COMMENCEMENT OF BROAD-SPECTRUM ANTIBIOTICS". INFORMATION RECEIVED FROM THE SALES REP.: "FLUID IN BURETROL WILL NOT DRAIN EASILY INTO COLLECTION BAG. REQUIRES LOTS OF MANIPULATION TO GET BURETROL TO DRAIN FLUID ALREADY COLLECTED IN TO THE COLLECTION BAG BELOW IT. THE DIRECTOR OF PICU TRIED MANIPULATION OF THE BAG BUT NO LUCK. REPLACED SYSTEM". (B)(6) 2014 ABILIO DUARTE IS CONTACT REP ABOUT COMMENTS PERTAINING TO SHUNT MALFUNCTION AND INFECTION. IT IS UNCLEAR IF THE DEVICES BELONG TO CODMAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430208 EXT DRAINAGE SYSTEM III WITHOUT VENT CATH SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Required Intervention