BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NV PRM 1LWR CLV 100"

    MDR report key: 2110015 · Received April 28, 2011

    Report

    Report Number
    9613251-2011-00083
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 12, 2011
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K030002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO HAZARDOUS CONTAMINATION, THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. 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 A LEAK OF A CHEMOTHERAPEUTIC AGENT. THE OPTION-LOK MALE ADAPTER OF THE TUBING SET WAS CONNECTED TO THE CLAVE Y-SITE OF A PRIMARY PLUMSET AND WAS BEING USED TO DELIVER AN UNSPECIFIED CHEMOTHERAPEUTIC AGENT. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, A LEAK OF SOLUTION WAS NOTED AT THE OPTION-LOK MALE ADAPTER. THE LEAK OF SOLUTION WAS CLEANED UP PER THE USER FACILITY'S PROTOCOL. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NV PRM 1LWR CLV 100" 80FPA FPA HOSPIRA LTD. NA 731284W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LIFESHIELD PRIMARY IV PLUMSET: LIST#11943, LOT#UNK