BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM LFS PRIM PMP

    MDR report key: 2063206 · Received March 22, 2011

    Report

    Report Number
    9615050-2011-00181
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K933326
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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. (B)(4).

    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 CHEMOTHERAPEUTIC AGENT. IT WAS REPORTED THAT "A FEW MINUTES" AFTER THE DELIVERY WAS INITIATED, THE SOLUTION LEAKED FROM THE "BOTTOM OF THE FILTER." THE SOLUTION THAT LEAKED WAS CLEANED UP ACCORDING TO 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 IN THERAPY CRITICAL FOR THIS PATIENT. NO MEDICAL INTERVENTIONS WERE PROVIDED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLM LFS PRIM PMP 80FPA FPA HOSPIRA COSTA RICA LTD. NA 880805H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK