BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECONDARY IV SET-SL/CE (50/CS)

    MDR report key: 2493268 · Received March 12, 2012

    Report

    Report Number
    9615050-2012-00233
    Event Type
    Malfunction
    Date Received
    March 12, 2012
    Date of Event
    February 13, 2012
    Report Date
    February 13, 2012
    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
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THE DEVICE WS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER 11953. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FPB AND HAS A 510K OF K920736. 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 TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF OXALIPLATIN. THE SECURE LOCK MALE ADAPTER OF THE TUBING SET WAS CONNECTED TO A CLAVE PORT ON THE CASSETTE OF A PLUMSET. AFTER AN UNSPECIFIED LENGTH OF TIME, SOLUTION LEAKED FROM THE CONNECTION OF THE TUBING TO THE SECURE LOCK MALE ADAPTER OF THE TUBING SET. THE TUBING SET WAS 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 ADDITIONAL INFORMATION WAS PROVIDED, INCLUDING IF THE SOLUTION THAT LEAKED WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECONDARY IV SET-SL/CE (50/CS) UNK FPA HOSPIRA COSTA RICA LTD. NA 102165G

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CLAVE PORT MALE ADAPTER PLUG: LIST # UNK,| MFR ICU MEDICAL INC.| PLUMSET: LIST #14000, LOT # UNK