BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS LF CONV PP OL 2 C

    MDR report key: 1621182 · Received March 1, 2010

    Report

    Report Number
    9615050-2010-00024
    Event Type
    Malfunction
    Date Received
    March 1, 2010
    Date of Event
    January 26, 2010
    Report Date
    February 1, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K052722
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL; (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED BACKFLOW OF IV FLUID FROM THE SECONDARY TUBING SET INTO THE PRIMARY SOLUTION CONTAINER. THE PRIMARY TUBING SET WAS BEING USED TO DELIVER 500ML OF NORMAL SALINE. AT AN UNSPECIFIED TIME, A SECONDARY TUBING SET WAS CONNECTED TO THE PRIMARY TUBING SET FOR PIGGYBACK DELIVERY OF AN UNSPECIFIED CONCENTRATION OF INTERFERON. THE PRIMARY SOLUTION CONTAINER WAS HUNG BELOW THE SECONDARY SOLUTION CONTAINER. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, IT WAS REPORTED THAT THE SECONDARY SOLUTION WAS NOTED TO HAVE BACKFLOWED INTO THE PRIMARY SOLUTION CONTAINER. THE SOLUTION THAT BACKFLOWED INTO THE PRIMARY SOLUTION CONTAINER WAS DELIVERED TO THE PT. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LS LF CONV PP OL 2 C 80FPA FPA HOSPIRA COSTA RICA LTD. NA 831755H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED SECONDARY SET, MFR UNK