BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTXF SYM CNVTP 2CLVE

    MDR report key: 1925826 · Received November 8, 2010

    Report

    Report Number
    9615050-2010-00225
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 11, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K041550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    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. 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 A LEAK OF A CHEMOTHERAPEUTIC AGENT AND AIR DISTAL TO THE FILTER. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF TAXOL AT AN UNSPECIFIED RATE VIA A SYMBIQ PUMP. IT WAS REPORTED THAT "A COUPLE OF MINUTES" AFTER THE DELIVERY WAS INITIATED, LEAKAGE OF SOLUTION WAS NOTED DISTAL TO THE FILTER. THE CUSTOMER CONTACT REPORTED THAT THE VOLUME OF SOLUTION THAT LEAKED ON TO THE FLOOR WAS "LESS THAN 30ML." THE SOLUTION THAT LEAKED WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL. THE NURSE ALSO REPORTED A "SMALL AMOUNT" OF AIR IN THE TUBING DISTAL TO THE FILTER. NO AIR WAS DELIVERED TO THE PT. 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 INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LTXF SYM CNVTP 2CLVE 80FRN FRN HOSPIRA COSTA RICA LTD. NA 932745H

    Patients

    Seq Age Sex Outcome Treatment
    1