BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3062321 · Received April 16, 2013

    Report

    Report Number
    3004209178-2013-06408
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    March 20, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP ANALYSIS FOUND NO ANOMALY. THE PUMP WAS FILLED WITH 20 ML. OF FLUID AND ASPIRATED 5 TIMES WITH NO ISSUES SEEN. THE PUMP WAS THEN FILLED WITH 10 ML. OF STERILE WATER AND ASPIRATED 5 TIMES WITH NO ISSUES SEEN. ALL THE PUMP LOGS WERE CLEAN, MEANING NO MOTOR STALLS, MOTOR STALL RECOVERIES, OR ERRORS OF ANY KIND WERE SEEN IN ANY OF THE PUMP LOGS.

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PUMP WAS NOT USED OR IMPLANTED IN A PATIENT. UPON WITHDRAWING THE FLUID, WHICH WAS NACL (SODIUM CHLORIDE) ONLY 12 ML WAS ABLE TO BE REMOVED. A WARM SALINE SOAK WAS TRIED HOWEVER, NOTHING MORE CAME OUT AND THEREFORE ANOTHER PUMP WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162543 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1