BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM LFS PRIM PMP

    MDR report key: 3172397 · Received June 5, 2013

    Report

    Report Number
    9615050-2013-01516
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 6, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K982159
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. 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. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF TOTAL PARENTERAL NUTRITION, AT AN UNSPECIFIED RATE. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE NURSE NOTED THAT THE PT'S BED SHEET WAS WET. THE CUSTOMER CONTACT REPORTED THAT 65 ML OF SOLUTION LEAKED FROM AN UNSPECIFIED AIR VENT OF THE FILTER 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249572 PLM LFS PRIM PMP 80FRN FRN HOSPIRA COSTA RICA LTD. NA 180035H

    Patients

    Seq Age Sex Outcome Treatment
    1