BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 1052396 · Received May 27, 2008

    Report

    Report Number
    6000030-2008-02830
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 25, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    A VOLUME DISCREPANCY WAS DISCOVERED AT PUMP REFILL. THE EXPECTED RESERVOIR VOLUME WAS 9 MLS; THE ACTUAL VOLUME ASPIRATED WAS 20 MLS. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM IN 2008. THE HCP WAS UNABLE TO ASPIRATE THE CATHETER THROUGH THE CATHETER ACCESS PORT. THE PUMP SITE WAS OPENED. WHEN THE CATHETER WAS TAKEN APART, SOME TISSUE WAS FOUND IN AND AROUND THE CONNECTOR. THE TISSUE WAS REMOVED AND THE HCP WAS ABLE TO EASILY ASPIRATE THE CATHETER. A DYE STUDY WAS COMPLETED WITHOUT DIFFICULTY. A ROLLER STUDY WAS PERFORMED AND THE PUMP WAS DETERMINED TO BE WORKING PROPERLY. THE DEVICE SYSTEM WAS RECONNECTED AND THE PUMP WAS REPROGRAMMED TO A MUCH LOWER DOSE. THE PATIENT WAS REPORTED TO BE DOING FINE THE NIGHT AFTER REVISION SURGERY. THE TYPE OF MEDICATION, CONCENTRATION AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED; DEVICE REGISTRATION SYSTEM INDICATES FENTANYL. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MANUFACTURING 8709SC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROGRAMMER MODEL 8840 LOT# UNKNOWN