BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, 1.2 M

    MDR report key: 18711453 · Received February 15, 2024

    Report

    Report Number
    9615050-2024-00138
    Event Type
    Malfunction
    Date Received
    February 15, 2024
    Date of Event
    August 7, 2023
    Report Date
    March 21, 2024
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K141789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    A VIDEO WAS RETURNED SHOWING A MICRON FILTER LEAKING FROM THE OUTLET FILTER. THE COMPLAINT FILTER LEAKAGE CAN BE CONFIRMED BASED ON THE VIDEO RETURNED BY THE CUSTOMER. ADDITIONALLY, A PICTURE OF THE PACKAGING SHOWING THE LOT NUMBER WAS RETURNED. WITHOUT THE RETURN OF THE USED SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A CAUSE CANNOT BE DETERMINED. THE LOT HISTORY WAS REVIEWED, NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION; HOWEVER, PHOTOS WERE PROVIDED. INVESTIGATION IS PENDING. E1-INITIAL REPORTER FACILITY NAME: (B)(6).

    Description of Event or Problem · 0

    THE EVENT INVOLVED A PRIMARY PLUM SET, LN 15443-31, LOTN 5983801. THE REPORTER STATED THAT THE PHOTOSENSITIVE SET LEAKED IN FILTER AREA WHILE IN USE TO ADMINISTER PARENTERAL NUTRITION TO A PATIENT. THE STATUS OF THE PRODUCT AT THE TIME OF EVENT WAS DURING INFUSION. THERE WERE TWO SETS INVOLVED IN THE EVENT, AND THAT THE SET WAS REMOVED, AND THE ADMINISTRATION OF PARENTAL NUTRITION WAS SUSPENDED. THERE WAS PATIENT INVOLVEMENT, BUT NO REPORT OF PATIENT HARM. THIS CAPTURES TWO OF TWO OCCURRENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2086711 PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, 1.2 M SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL COSTA RICA LTD. 5983801

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TOTAL PARENTERAL NUTRITION, UNK MFR