BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONV PN SEC MACRO OL

    MDR report key: 1231102 · Received October 30, 2008

    Report

    Report Number
    9613251-2008-00371
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    January 1, 2008
    Report Date
    October 9, 2008
    Manufacturer
    HOSPIRA, LTD
    Product Code
    FPA
    PMA / PMN Number
    K030002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THE DEVICES WERE DISCARDED.

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF NO FLOW. THE PRIMARY TUBING SETS WERE BEING USED TO DELIVER UNSPECIFIED SOLUTIONS VIA SYMBIQ PUMPS. AT UNSPECIFIED TIMES, THE SECONDARY TUBING SETS WERE CONNECTED TO THE PRIMARY TUBING SETS FOR PIGGYBACK DELIVERY OF UNSPECIFIED MEDICATIONS. THE PRIMARY SOLUTION CONTAINERS WERE LOWERED BELOW THE SECONDARY SOLUTION CONTAINERS USING ONE OR TWO EXTENSION HANGERS. IT WAS REPORTED AFTER UNSPECIFIED LENGTHS OF TIME, THE NURSES NOTED THE SECONDARY MEDICATIONS STOPPED INFUSING. THE PRIMARY TUBING SETS WERE CLAMPED AND THE SECONDARY THERAPIES WERE RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 SYMBIQ PRIMARY TUBING SET