BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3964072 · Received May 5, 2014

    Report

    Report Number
    9615050-2014-03212
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    January 1, 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 DEVICES WERE 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

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF BACKFLOW OF SOLUTION FROM THE SECONDARY SOLUTION CONTAINER INTO THE PRIMARY SOLUTION CONTAINER. ON UNSPECIFIED DATES, THE PRIMARY TUBING SETS WERE USED TO DELIVER UNSPECIFIED MEDICATIONS. THE PRIMARY SOLUTION CONTAINERS WERE HUNG LOWER THAN THE SECONDARY SOLUTION CONTAINERS. AT UNSPECIFIED TIMES, THE MALE ADAPTER OF SECONDARY TUBING SETS WERE CONNECTED TO THE CLAVE Y-SITE OF THE PRIMARY TUBING SETS FOR A PIGGYBACK DELIVERY OF UNSPECIFIED CONCENTRATIONS OF OXALIPLATIN AT UNSPECIFIED RATES, VIA PUMPS. THE CUSTOMER CONTACT REPORTED APPROXIMATELY 30 MINUTES PRIOR TO THE COMPLETION OF THE INFUSIONS, THE NURSES NOTED THAT THE SECONDARY MEDICATIONS HAD BACKFLOWED INTO THE PRIMARY SOLUTION CONTAINERS. IT WAS REPORTED THAT THE ENTIRE VOLUME OF THE PRIMARY SOLUTION CONTAINERS WERE DELIVERED TO THE PATIENTS TO ENSURE THE FULL DOSES OF OXALIPLATIN WERE DELIVERED TO THE PATIENTS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAYS IN THERAPIES CRITICAL TO THESE PATIENTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268328 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 PUMPS, MFR: (B)(4)| UNSPECIFIED SECONDARY TUBING SETS,LIST#UNK,LOT#UNK