BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3964058 · Received May 5, 2014

    Report

    Report Number
    9615050-2014-03213
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    March 24, 2014
    Report Date
    April 11, 2014
    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 CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. A REPRESENTATIVE DEVICE FROM AN UNSPECIFIED LOT IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED BACKFLOW OF SOLUTION FROM THE SECONDARY SOLUTION CONTAINER INTO THE PRIMARY SOLUTION CONTAINER. THE PRIMARY TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION. AT AN UNSPECIFIED TIME, THE MALE ADAPTER OF A SECONDARY TUBING SET WAS CONNECTED TO THE CLAVE Y-SITE OF THE PRIMARY TUBING SET FOR A PIGGYBACK DELIVERY OF AN UNSPECIFIED RATE, VIA A PUMP. THE PRIMARY SOLUTION CONTAINER WAS HUNG LOWER THAN THE SECONDARY SOLUTION CONTAINER. THE CUSTOMER CONTACT REPORTED APPROXIMATELY 30 MINUTES PRIOR TO THE COMPLETION OF THE INFUSION, THE NURSE NOTED THAT THE SECONDARY SOLUTION CONTAINER WAS EMPTY AND THAT THE SECONDARY MEDICATION HAD BACKFLOWED INTO THE PRIMARY SOLUTION CONTAINER. IT WAS REPORTED THAT THE ENTIRE VOLUME OF THE PRIMARY SOLUTION CONTAINER WAS DELIVERED TO THE PATIENT TO ENSURE THE FULL DOSE OF OXALIPLATIN WAS DELIVERED TO THE PATIENT. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY IN THERAPY CRITICAL TO THE PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268138 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 SPECTRUM INFUSION PUMP, MFR: BAXTER HEALTHCARE| UNSPECIFIED SECONDARY TUBING SET, LIST#UNK,LOT#UNK