BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONV PN SEC MACRO OL

    MDR report key: 1231125 · Received October 30, 2008

    Report

    Report Number
    9613251-2008-00369
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 10, 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 DEVICE WAS DISCARDED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED NO FLOW. THE PRIMARY TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED SOLUTION VIA A SYMBIQ PUMP. AT AN UNSPECIFIED TIME, A SECONDARY TUBING SET WAS CONNECTED TO THE PRIMARY TUBING SET FOR PIGGYBACK DELIVERY OF IMMUNOGLOBULIN G. THE PRIMARY SOLUTION CONTAINER WAS LOWERED BELOW THE SECONDARY SOLUTION CONTAINER USING ONE EXTENSION HANGER. IT WAS REPORTED AFTER THE SECONDARY DELIVERY RATE WAS INCREASED FROM 50ML/HR TO 100ML/HR, THE SECONDARY SOLUTION STOPPED INFUSING AND THE PRIMARY SOLUTION BEGAN INFUSING. THE PRIMARY TUBING SET WAS CLAMPED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. 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 642214W

    Patients

    Seq Age Sex Outcome Treatment
    1 SYMBIQ PRIMARY TUBING SET| LOT# 631505H