BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIM SYM SET 2 CL

    MDR report key: 3070169 · Received April 15, 2013

    Report

    Report Number
    9615050-2013-00738
    Event Type
    Malfunction
    Date Received
    April 15, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 18, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K103344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED BACKFLOW OF FLUID FROM THE SECONDARY SOLUTION CONTAINER INTO THE PRIMARY TUBING SET. THE PRIMARY TUBING SET WAS BEING USED TO DELIVER 500 ML OF AN UNSPECIFIED MEDICATION, AT A RATE OF 50 ML/HR, VIA A SYMBIQ PUMP. AT AN UNSPECIFIED TIME, THE OPTION-LOK MALE ADAPTER OF S SECONDARY TUBING SET WAS CONNECTED TO AN UNSPECIFIED CLAVE Y-SITE OF THE PRIMARY TUBING SET FOR A PIGGYBACK DELIVERY OF 100 ML OF AN UNSPECIFIED CONCENTRATION OF POTASSIUM CHLORIDE, AT AN UNSPECIFIED RATE. THE PRIMARY SOLUTION CONTAINER WAS HUNG LOWER THAN THE SECONDARY SOLUTION CONTAINER. THE CUSTOMER CONTACT REPORTED THAT IMMEDIATELY AFTER THE DELIVERY WAS STARTED, THE NURSE REPORTED THAT BACKFLOW OF SOLUTION FROM THE SECONDARY SOLUTION CONTAINER INTO THE PRIMARY SOLUTION CONTAINER WAS NOTED. THE TUBING SETS WERE REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REPORTED. DURING TESTING AT THE USER FACILITY, NO POTASSIUM CHLORIDE WAS FOUND IN SOLUTION CONTAINER; HOWEVER, POTASSIUM CHLORIDE WAS NOTED IN THE SAMPLE OBTAINED FROM THE PRIMARY DRIP CHAMBER. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161565 PRIM SYM SET 2 CL 80FPA FPA HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SECONDARY TUBING SET, LIST #14230, LOT #UNK