BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIM SYM SET 2 CL

    MDR report key: 2903727 · Received January 4, 2013

    Report

    Report Number
    9615050-2013-00017
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 6, 2012
    Manufacturer
    HOSPIRA COSTA 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 BACKFLOW OF SOLUTION FROM THE PRIMARY SOLUTION CONTAINER INTO THE SECONDARY SOLUTION CONTAINER. ON AN UNSPECIFIED DATE, THE PRIMARY TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF NORMAL SALINE WITH 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 CONCENTRATION OF RITUXIMAB. THE PRIMARY SOLUTION CONTAINER WAS HUNG LOWER THAN THE SECONDARY SOLUTION CONTAINER. IT WAS REPORTED THAT PRIOR TO THE NURSE LEAVING THE PT'S ROOM, IT WAS NOTED THAT SOLUTION WAS DELIVERING ON THE SECONDARY LINE. ONE HOUR AFTER THE DELIVERY WAS STARTED, THE NURSE WENT INTO THE PT'S ROOM TO INCREASE THE DELIVERY RATE AND NOTED THE RITUXIMAB CONTAINER WAS FULL OF FLUID. IT WAS REPORTED THAT THE RITUXIMAB BAG CONTAINED MORE SOLUTION THAN ORIGINALLY STARTED. THE CUSTOMER CONTACT REPORTED THE PRIMARY TUBING SET WAS CLAMPED, PROXIMAL TO PUMP AND THERAPY WAS RESUMED. 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, THE SECONDARY TUBING SET, AND THE SOLUTION CONTAINERS WERE REPLACED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4179 PRIM SYM SET 2 CL 80FPA FPA HOSPIRA COSTA RICA LTD. NA 211975G

    Patients

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