BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDEX

    MDR report key: 1160784 · Received August 8, 2008

    Report

    Report Number
    1160784
    Event Type
    Malfunction
    Date Received
    August 8, 2008
    Date of Event
    July 18, 2008
    Report Date
    August 8, 2008
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NURSE WAS UNABLE TO INFUSE MEDICATION THROUGH TUBING. THE INFUSION PUMP KEPT ALARMING AND WOULD NOT INFUSE THE MEDICATION. RN SAID THAT NO CLAMPS WERE CLAMPED, THE INFUSION PUMP WAS WORKING PROPERLY, BUT THE RN WAS UNABLE TO FORCE MEDICATION THROUGH TUBING WHEN CONNECTED TO THE PATIENT. THERE WAS TOO MUCH RESISTANCE. WHEN TUBING WAS CONNECTED THE PATIENT'S PICC, IT FLUSHED EASILY WITH NORMAL SALINE. TWO MORE ATTEMPTS AT CHANGING THE TUBING WITH THE SAME LOT NUMBER WERE UNSUCCESSFUL. WHEN AN ALTERNATE LOT NUMBER WAS USED, THE RN HAD NO PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDEX TUBING, IV, MICROBORE FPA SMITHS MEDICAL 536040C 34F23D021

    Patients

    Seq Age Sex Outcome Treatment
    1 *