BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM MICDRP NITRO OL

    MDR report key: 3070168 · Received April 15, 2013

    Report

    Report Number
    9615050-2013-00737
    Event Type
    Malfunction
    Date Received
    April 15, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    HOSPIRA HOLDINGS DE 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 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 TO DELIVER AN UNSPECIFIED VOLUME OF AN UNSPECIFIED MEDICATION, AT AN UNSPECIFIED RATE, VIA A PLUM PUMP. IT WAS REPORTED THAT DURING PRIMING OF THE TUBING SET PRIOR TO PT USE, AN UNSPECIFIED VOLUME OF SOLUTION LEAKED FROM UNSPECIFIED LOCATION OF THE CASSETTE OF THE TUBING SET. THE TUBING SET WAS REPLACED AND THE THERAPY WAS INITIATED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161878 PLM MICDRP NITRO OL 80FRN FRN HOSPIRA HOLDINGS DE COSTA RICA LTD. NA 171515H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA