BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS LF CONV PP OL 2 C

    MDR report key: 1426526 · Received April 7, 2009

    Report

    Report Number
    9615050-2009-00076
    Event Type
    Malfunction
    Date Received
    April 7, 2009
    Date of Event
    March 6, 2009
    Report Date
    March 13, 2009
    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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED BACKFLOW OF FLUID FROM THE SECONDARY SOLUTION CONTAINER INTO THE PRIMARY SOLUTION CONTAINER. THE PRIMARY TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF NORMAL SALINE VIA AN UNSPECIFIED PUMP. THE SECONDARY TUBING SET WAS BEING USED FOR PIGGYBACK DELIVERY OF AN UNSPECIFIED CHEMOTHERAPEUTIC SOLUTION AT A RATE BETWEEN 500ML/HR AND 1600ML/HR. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, IT WAS REPORTED THAT THE SECONDARY SOLUTION BACKFLOWED INTO THE PRIMARY SOLUTION CONTAINER. THE PRIMARY TUBING SET AND THE PRIMARY AND SECONDARY SOLUTION CONTAINERS WERE REPLACED, AND THE THERAPIES WERE RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS. 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 712205H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MANUFACTURED BY SIGMA| UNSPECIFIED PUMP