BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 1193417 · Received October 7, 2008

    Report

    Report Number
    6000030-2008-06387
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 9, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0745-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PUMP HAD MORE VOLUME THAN EXPECTED. THE EXPECTED RESERVOIR VOLUME WAS 2.2 MLS; THE ACTUAL VOLUME WAS 16 MLS. NO PATIENT SYMPTOMS WERE REPORTED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR CATHETER: MODEL 8703W| EXPLANTED:| PROGRAMMER: MODEL PROGRAMMER