BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MEDICATION CASSETTE RESERVOIR

    MDR report key: 21825058 · Received April 11, 2025

    Report

    Report Number
    3012307300-2025-04189
    Event Type
    Malfunction
    Date Received
    April 11, 2025
    Date of Event
    March 1, 2025
    Report Date
    September 5, 2025
    Manufacturer
    ICU MEDICAL, INC
    Product Code
    FPA
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED. THE CUSTOMER INDICATED THERE WERE 23 AFFECTED DEVICES HOWEVER THEY DID NOT PROVIDE ANY PHOTOS OR SAMPLES TO VERIFY THIS INFORMATION. H3, H6: INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    D3: MFG ESTABLISHMENT NAME; ICU MEDICAL, INC. D9: DATE RETURNED TO MFG; 7/8/2025. DEVICE EVALUATION: FIVE USED DEVICES RECEIVED FOR DEVICE ANALYSIS. SERVICE HISTORY REVIEW IDENTIFIED THE COMPLAINT WAS NOT RELATED TO A PREVIOUS SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. FUNCTIONAL TESTING AND VISUAL INSPECTION WAS PERFORMED DURING ANALYSIS. THE CUSTOMER REPORTED COMPLAINT WAS CONFIRMED; LOOSE PARTICULATES WERE FOUND WITHIN THE CASSETTE. THE ROOT CAUSE COULD NOT BE IDENTIFIED, BUT IT WILL BE ADDRESSED UNDER A FORMAL CAPA INVESTIGATION. NO ADDITIONAL INVESTIGATION ACTIVITIES ARE PENDING AT THE COMPLAINT LEVEL.

    Additional Manufacturer Narrative · 0

    NO PRODUCT SAMPLE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE PRODUCT'S HISTORY RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMANCES NOR SERVICE-RELATED ISSUES THAT WOULD HAVE RESULTED IN THE REPORTED COMPLAINT. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE PARTICLES IN THE INFUSION BAG OF THE MEDICATION CASSETTE. THE INITIAL REPORTED WAS ABLE TO ISOLATE A PARTICLE FROM THE INFUSION BAG OF A MEDICATION CASSETTE AND ALSO IDENTIFY IT. THEY HAVE PERFORMED AN INITIAL PRODUCTION CHECK (IPC) MEASUREMENT IN WHICH THE REPORTER FOUND A MATCH BETWEEN THE PACKAGING MATERIAL AND THE PARTICLE THAT THEY HAVE BEEN ABLE TO IDENTIFY FROM THE INTERNAL INFUSION BAG OF THE MEDICATION CASSETTE. THIS PARTICLE MATCHES THE SPECTRUM OF POLYETHYLENE. IT IS KNOWN THAT THE CASSETTES WERE STERILIZED WITH ETHYLENE OXIDE; AND THIS WAS SUCKED THROUGH THE CASSETTE UNDER VACUUM. IT WAS STATED THAT THE CURRENT PERCENTAGE OF REJECTION FOR THIS LOT WAS 6%. THE CASSETTES IN QUESTION HAVE BEEN USED IN PRODUCTION BUT HAVE BEEN COMPLETELY EMPTIED OF FLUIDS. THE EVENT OCCURRED DURING THE INSPECTION OF FILLED MEDICATION CASSETTES. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079938 CADD MEDICATION CASSETTE RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL, INC 7302 6012471

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown