BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS LF IV SET CONVRT PP W/BCCK VLV 2CLAVE

    MDR report key: 2462766 · Received February 14, 2012

    Report

    Report Number
    9615050-2012-00127
    Event Type
    Malfunction
    Date Received
    February 14, 2012
    Date of Event
    January 20, 2012
    Report Date
    January 20, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K052722
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATED IS NOT COMPLETE. 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 FLUID FROM THE SECONDARY SOLUTION CONTAINER INTO THE PRIMARY SOLUTION CONTAINER. THE PRIMARY TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED SOLUTION, AT AN UNSPECIFIED RATE, VIA GRAVITY. AT AN UNSPECIFIED TIME, THE MALE ADAPTER OF A SECONDARY TUBING SET WAS CONNECTED TO THE PROXIMAL CLAVE Y-SITE ON THE PRIMARY TUBING SET FOR PIGGYBACK DELIVERY OF AN UNSPECIFIED CONCENTRATION OF CARBOPLATIN. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE NURSE NOTED BACKFLOW OF SOLUTION FROM THE SECONDARY SOLUTION CONTAINER INTO THE PRIMARY SOLUTION CONTAINER. 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, INCLUDING IF THE TUBING SETS WERE REPLACED AND THE THERAPY WAS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LS LF IV SET CONVRT PP W/BCCK VLV 2CLAVE 80FPA FPA HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LOT #UNK| UNSPECIFIED SECONDARY TUBING SET: LIST #UNK,