BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHROMED EL

    MDR report key: 620620 · Received July 11, 2005

    Report

    Report Number
    6000030-2005-01062
    Event Type
    Other
    Date Received
    July 11, 2005
    Date of Event
    June 21, 2005
    Report Date
    July 7, 2005
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HCP REPORTED THE PT WAS EXPERIENCING A PAINFUL POCKET AND A DECREASE IN PAIN RELIEF. IT WAS ALSO REPORTED THERE WAS A LOW BATTERY ALARM OCCURRING. A CULTURE WAS DONE - THE SOURCE AND RESULTS WERE NOT REPORTED. THE PUP AND CATHETER WERE REPLACED DUE TO AN INFECTION. THE HCP WAS QUESTIONING A CATHETER LEAK OR OCCLUSION ALSO. A FOLLOW UP REPORT WILL BE SENT WHEN ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL PUMP LKK RICE CREEK MANUFACTURING 8827L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| O