BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIM SYM SET 2 CL

    MDR report key: 2903730 · Received January 4, 2013

    Report

    Report Number
    9615050-2013-00019
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 6, 2012
    Manufacturer
    HOSPIRA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K110901
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    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 CONCURRENT FLOW. ON AN UNSPECIFIED DATE, THE PRIMARY TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF SODIUM CHLORIDE AND AN UNSPECIFIED CONCENTRATION OF POTASSIUM CHLORIDE, AT AN UNSPECIFIED RATE, VIA A SYMBIQ PUMP. NO SPECIFIC PUMP PROGRAMMING PARAMETERS WERE PROVIDED. AT AN UNSPECIFIED TIME, THE OPTION-LOK MALE ADAPTER OF A SECONDARY TUBING SET WAS CONNECTED TO AN UNSPECIFIED LOCATION ON THE PRIMARY TUBING SET FOR PIGGYBACK DELIVERY OF AN UNSPECIFIED MEDICATION. THE PRIMARY SOLUTION CONTAINER WAS HUNG LOWER THAN THE SECONDARY SOLUTION CONTAINER. AFTER AN UNSPECIFIED LENGTH OF TIME AFTER THE PIGGYBACK DELIVERY WAS STARTED, THE NURSE WENT TO CHECK ON THE PT AND FOUND BOTH THE PRIMARY AND SECONDARY TUBING SETS WERE DRIPPING AND WHEN THE PUMP ALARMED THAT THE INFUSION WAS COMPLETE, AN UNSPECIFIED VOLUME OF MEDICATION REMAINED IN THE SECONDARY CONTAINER. THE CUSTOMER CONTACT REPORTED THE PRIMARY TUBING SET WAS CLAMPED PROXIMAL TO PUMP AND THERAPY WAS RESUMED. THE CUSTOMER CONTACT INDICATED THAT THE TIME TO DELIVER ALL OF THE SECONDARY MEDICATION WAS DOUBLED FROM THE INTENDED DURATION. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REPORTED. IT WAS REPORTED THAT AFTER THE THERAPY WAS COMPLETED, THE PRIMARY TUBING SET AND THE SECONDARY TUBING SET WERE REPLACED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4332 PRIM SYM SET 2 CL 80FPA FPA HOSPIRA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SYMBIQ PUMP, LIST NUMBER UNK, SN UNK| SECONDARY TUBING SET, LIST #14230, LOT #180174W