BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17010441 · Received May 26, 2023

    Report

    Report Number
    9615050-2023-00150
    Event Type
    Malfunction
    Date Received
    May 26, 2023
    Date of Event
    March 24, 2023
    Report Date
    May 5, 2023
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FPA
    UDI-DI
    10887709100883
    PMA / PMN Number
    K141789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT OF DISCONNECTION/LOOSE CONNECTION ON THE RETURNED USED ONE (1) USED. LIST #14001-31, PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 272 CM; LOT #5973268 SET COULD NOT BE CONFIRMED. THE PRODUCT WAS TESTED PER PRODUCT SPECIFICATION. THERE NO LEAKS OBSERVED ANYWHERE ALONG THE FLUID PATH. NO DISCONNECTION OBSERVED. NO LOOSE CONNECTIONS OBSERVED. THE RETURNED USED 14001-31, PRIMARY PLUM SET MET PRODUCT SPECIFICATION THE LOT HISTORY WAS REVIEWED AND NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. UPDATE D9- DEVICE RECEIVED 5/24/2023.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION; HOWEVER, TESTING HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A PRIMARY PLUM SET WHERE IT WAS REPORTED THAT WHEN STARTING THE LEVOSIMEDAN MEDICATION INFUSION THROUGH THE XL SET, CONNECTED IN "Y" WITH THE FUROSEMIDE MEDICATION INFUSION AND THE MACRODRIP; THE SET CAME LOOSE SEVERAL TIMES AND DISCONNECTED BETWEEN ONE MOVEMENT AND ANOTHER, CAUSING MEDICATION SPILLS AND NOT ALLOWING A GOOD, SECURE GRIP BETWEEN THE PORT OF THE SET AND THE MACRODRIP CONNECTOR. NO HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1436983 PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL COSTA RICA LTD. 5973268 10887709100883

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown FUROSEMIDE, MFR UNK| LEVOSIMEDAN, MFR UNK