BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM LFS PRIM PMP

    MDR report key: 2193500 · Received July 21, 2011

    Report

    Report Number
    9615050-2011-00545
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 18, 2011
    Report Date
    June 24, 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

    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.

    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 VIA A PLUM PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, A LEAK OF SOLUTION WAS NOTED FROM AN UNSPECIFIED LOCATION OF THE FILTER OF THE TUBING SET. 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 INCLUDING IF THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED AND IF THE LEAK OF SOLUTION WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLM LFS PRIM PMP 80FPA FPA HOSPIRA COSTA RICA LTD. NA 941855H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK