BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2059958 · Received March 14, 2011

    Report

    Report Number
    9615050-2011-00156
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 16, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    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. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THE LIST NUMBER HAS A COMMON DEVICE NAME OF 80FPA AND A 510K OF K052722. 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 250ML OF 0.9% SODIUM CHLORIDE AT AN UNSPECIFIED RATE. A SECONDARY TUBING SET WAS CONNECTED TO THE PROXIMAL CLAVE Y-SITE OF THE PRIMARY TUBING SET FOR PIGGYBACK DELIVERY OF AN UNSPECIFIED CONCENTRATION OF TAXOL IN 292ML, AT A RATE OF 292ML/HR, VIA A SIGMA SPECTRUM PUMP. THE PRIMARY SOLUTION CONTAINER WAS HUNG LOWER THAN THE SECONDARY SOLUTION CONTAINER. THE PRIMARY SOLUTION CONTAINER WAS REPORTED TO HAVE 180ML OF SOLUTION REMAINING. IT WAS REPORTED THAT FIFTEEN MINUTES AFTER THE DELIVERY WAS STARTED, THE NURSE NOTED THAT THE SECONDARY SOLUTION CONTAINER WAS EMPTY AND THE PRIMARY SOLUTION CONTAINER APPEARED "FULL." THE PHYSICIAN WAS NOTIFIED AND ORDERED A SECOND DOSE OF TAXOL. THE SOLUTION CONTAINERS AND THE TUBING SETS WERE REPLACED 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 ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LS LF IV SET CONVRT PP W/BCCK VLV 2CLAVE UNK FPA HOSPIRA COSTA RICA LTD. NA 902125H

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR SIGMA SPECTRUM PUMP, MFR BY SIGMA INTERNATIONAL| SECONDARY TUBING SET, LIST #UNK, LOT #UNK