BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIM SYM SET 2 CL

    MDR report key: 2870066 · Received December 10, 2012

    Report

    Report Number
    9615050-2012-01491
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 11, 2012
    Report Date
    November 12, 2012
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. 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 BACKFLOW OF FLUID FROM THE SECONDARY SOLUTION CONTAINER INTO THE DRIP CHAMBER OF THE PRIMARY TUBING SET. THE PRIMARY TUBING SET WAS BEING USED TO DELIVER 1000 ML OF 5% DEXTROSE IN 0.45% NORMAL SALINE, AT AN UNSPECIFIED RATE, VIA A SYMBIQ PUMP. AT AN UNSPECIFIED TIME, THE OPTION-LOK MALE ADAPTER OF A SECONDARY TUBING SET WAS CONNECTED TO THE PROXIMAL CLAVE Y-SITE OF THE PRIMARY TUBING SET FOR A PIGGYBACK DELIVERY OF POTASSIUM CHLORIDE 20 MEQ/100 ML, AT A RATE OF 10 MEQ/HR FOR A DURATION OF 2 HOURS. THE PRIMARY SOLUTION CONTAINER WAS HUNG LOWER THAN THE SECONDARY SOLUTION CONTAINER. THE CUSTOMER CONTACT REPORTED PRIOR TO THE START OF THE PIGGYBACK DELIVERY, BACKFLOW OF SOLUTION FROM THE SECONDARY SOLUTION CONTAINER INTO THE DRIP CHAMBER OF THE PRIMARY TUBING SET WAS NOTED. THE TUBING SETS WERE REPLACED AND THE THERAPY WAS INITIATED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

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