BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 553860 · Received April 27, 2004

    Report

    Report Number
    6000030-2004-00541
    Event Type
    Malfunction
    Date Received
    April 27, 2004
    Date of Event
    April 14, 2004
    Report Date
    April 20, 2004
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HCP REPORTED THAT AT THE PUMP REFILL IN 12/2003, THE EXPECTED RESERVOIR VOLUME WAS 12CC AND THE ACTUAL WAS 17.5CC. AT THE NEXT REFILL IN 02/2004, THE EXPECTEC RESERVOIR VOLUME WAS 12.5CC AND THE ACTUAL WAS 17.1CC. A ROTOR TEST WAS DONE. THE RESULTS WERE NOT REPORTED. THE PUMP AND CATHETER WERE EXPLANTED AND RETURNED TO THE MANUFACTURER FOR ANALYSIS. A FOLLOW UP REPORT WILL BE SENT WHEN ADDITIONAL INFO IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL PUMP LKK RICE CREEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization