BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONV PN SEC MACR LKN

    MDR report key: 2397140 · Received November 29, 2011

    Report

    Report Number
    9613251-2011-00247
    Event Type
    Malfunction
    Date Received
    November 29, 2011
    Date of Event
    November 1, 2011
    Report Date
    November 1, 2011
    Manufacturer
    HOSPIRA, LTD
    Product Code
    FPK
    PMA / PMN Number
    K063239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED NO FLOW. A PRIMARY TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION, AT AN UNSPECIFIED RATE, VIA A PUMP. AT AN UNSPECIFIED TIME, THE OPTION-LOK MALE ADAPTER OF THE SECONDARY TUBING SET WAS CONNECTED TO A NEEDLELESS VALVE CONNECTOR ON THE PRIMARY TUBING SET FOR PIGGYBACK DELIVERY OF AN UNSPECIFIED CONCENTRATION OF INTRAVENOUS IMMUNOGLOBULIN, AT AN UNSPECIFIED RATE. IT WAS REPORTED THAT THE PRIMARY SOLUTION CONTAINER WAS LOWERED BELOW THE SECONDARY SOLUTION CONTAINER. IT WAS REPORTED THAT AFTER THE SECONDARY MEDICATION DELIVERY WAS STARTED, NO FLOW OF SOLUTION WAS NOTED. THE SECONDARY TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTS OF ADVERSE PT EFFECTS AND NO REPORTED DELAYS IN THERAPY CRITICAL TO THE PT. 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 MACR LKN 80FPK FPK HOSPIRA, LTD NA UNK4W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MFR CAREFUSION CORP| ALARIS PRIMARY TUBING SET: LIST 2420-0007, LOT#UNK| ALARIS PUMP, MFR CAREFUSION CORP