BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOL150X60 DL CHN PLM

    MDR report key: 2742046 · Received September 5, 2012

    Report

    Report Number
    9615050-2012-01036
    Event Type
    Malfunction
    Date Received
    September 5, 2012
    Date of Event
    July 13, 2012
    Report Date
    August 8, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K865060
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 PARTICULATE. THE SOLUSET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF TOTAL PARENTERAL NUTRITION (TPN), AT AN UNSPECIFIED RATE, VIA PLUM PUMP. AT 1557, THE DELIVERY WAS STARTED. THE CUSTOMER CONTACT REPORTED THAT AT APPROXIMATELY 2045, A PARTICULATE WAS NOTED INSIDE THE SOLUSET. IT WAS REPORTED THAT THE PARTICULATE WAS NOTED TO BE FLOATING "RIGHT ON TOP OF THE FLUIDS IN THE BURETROL." THE CUSTOMER CONTACT REPORTED THAT THE PARTICULATE WAS APPROXIMATELY 3MM LONG, WITH A SMALL CURVE ON THE END. IT WAS REPORTED THAT THE NURSE STOPPED THE DELIVERY AND THE TUBING SET WAS REPLACED. IT WAS REPORTED THAT THE PHARMACY WAS NOTIFIED AND A DELIVERY OF 10% DEXTROSE IN WATER, AT AN UNSPECIFIED RATE, WAS INITIATED UNTIL THE REPLACEMENT CONTAINER OF TPN WAS OBTAINED. IT WAS REPORTED THAT BETWEEN 2100 AND 2150, THE REPLACEMENT TPN SOLUTION CONTAINER WAS MADE 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 REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOL150X60 DL CHN PLM 80FRN FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA