BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONV PN SEC MACR LKN

    MDR report key: 2397166 · Received November 29, 2011

    Report

    Report Number
    9613251-2011-00251
    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 CUSTOMER INDICATED THE DEVICES WERE DISCARDED. THE DEVICES WERE NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICES COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    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, AT UNSPECIFIED RATES, VIA PUMPS. AT UNSPECIFIED TIMES, THE OPTION-LOK MALE ADAPTERS OF THE SECONDARY TUBING SETS WERE CONNECTED TO NEEDLELESS VALVE CONNECTOR Y-SITES ON THE PRIMARY TUBING SETS FOR PIGGYBACK DELIVERIES OF UNSPECIFIED SOLUTIONS. IT WAS REPORTED THAT THE PRIMARY SOLUTION CONTAINERS WERE HUNG LOWER THAN THE SECONDARY SOLUTION CONTAINERS. IT WAS REPORTED THAT AFTER THE DELIVERIES WERE STARTED, NO FLOW OF SOLUTIONS WERE NOTED. THE SECONDARY TUBING SETS WERE REPLACED AND THE THERAPIES WERE RESUMED. THERE WERE NO REPORTS OF ADVERSE PT EFFECTS AND NO REPORTED DELAYS IN CRITICAL THERAPIES CRITICAL TO THESE PTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO 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 NA MFR CAREFUSION CORPORATION| ALARIS PRIMARY TUBING SETS,LIST#2420-0007, LOT#UNK| ALARIS PUMPS: MFR CAREFUSION CORPORATION