BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONV PN SEC MACRO OL

    MDR report key: 1033554 · Received April 24, 2008

    Report

    Report Number
    9613251-2008-00106
    Event Type
    Malfunction
    Date Received
    April 24, 2008
    Date of Event
    March 1, 2008
    Report Date
    April 2, 2008
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K030002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED NO FLOW. THE SECONDARY TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED SOLUTION. IT WAS REPORTED THAT AFTER THE SECONDARY TUBING SET WAS CONNECTED TO AN UNSPECIFIED ALARIS SMARTSITE TUBING SET, THE SOLUTION IN THE SECONDARY TUBING SET WOULD NOT FLOW. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONV PN SEC MACRO OL 80-FPA FPA HOSPIRA LTD. NA 600694W

    Patients

    Seq Age Sex Outcome Treatment
    1 ADULT UNSPECIFIED SMARTSITE TUBING SET| MANUFACTURED BY ALARIS