BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 2050191 · Received April 1, 2011

    Report

    Report Number
    6000030-2011-02499
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MANUFACTURE EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE.

    Description of Event or Problem · 1

    A PUMP MEMORY ERROR OCCURRED DURING PUMP UPDATE OR INTERROGATION. THE PUMP WAS PROGRAMMED TO STOPPED MODE. THE PUMP WAS REPROGRAMMED WHICH RESOLVED THE ISSUE. A VOLUME DISCREPANCY WAS ALSO REPORTED. THE ACTUAL RESIDUAL VOLUME WAS 2.1 ML AND THE EXPECTED RESIDUAL VOLUME WAS 1.7 ML. IT WAS LATER REPORTED THAT THE PUMP WAS "NOT DEFECTIVE." A PUMP REPLACEMENT WAS SCHEDULED "DUE TO AGE." NO PATIENT SYMPTOMS WERE REPORTED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR EXPLANTED:| CATHETER: MODEL 8709, LOT# L80788| IMPLANTED: