BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM MICDP NITRO OL

    MDR report key: 3874504 · Received April 22, 2014

    Report

    Report Number
    9615050-2014-02880
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 25, 2014
    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 CUSTOMER INDICATED THE DEVICE WAS DISCARDED. DURING THE INVESTIGATION, NO POSSIBLE CAUSES FOR THE CUSTOMER REPORTED LEAK FROM THE AIR FILTER ASSEMBLY ON THE PIERCING PIN OF THE TUBING SET WAS IDENTIFIED. 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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A LEAK. THE TUBING SET WAS BEING USED TO DELIVERY AN UNSPECIFIED VOLUME OF AN UNSPECIFIED CONCENTRATION OF PHYSIOL, AT A RATE OF 30ML/HR. IT WAS REPORTED THAT THE PHYSIOL WAS IN A GLASS BOTTLE. IT WAS REPORTED THAT THE VENT COVER ON THE PIERCING PIN OF THE TUBING SET WAS OPENED FOR THE GLASS BOTTLE DELIVERY. IT WAS REPORTED THAT ONE HOUR AFTER THE DELIVERY WAS STARTED AN UNSPECIFIED VOLUME OF SOLUTION LEAKED FROM THE VENT ON THE PIERCING PIN OF THE TUBING SET. THERE WERE NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243106 PLM MICDP NITRO OL 80FRN FRN HOSPIRA COSTA RICA LTD. NA 330735H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK