BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD ADMINISTRATION SET

    MDR report key: 24701670 · Received March 26, 2026

    Report

    Report Number
    3012307300-2026-02954
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    March 6, 2026
    Report Date
    March 26, 2026
    Manufacturer
    ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V
    Product Code
    FPA
    UDI-DI
    10610586029646
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    AN EMAIL WAS RECEIVED REGARDING A CADD ADMINISTRATION SET WITH ITEM 21-7322-24 AND LOT 6140818. IT WAS REPORTED THAT THE PUMP HAD ALARMED ¿COMPLETED.¿ THE REMAINING RESERVOIR VOLUME HAD BEEN 60 ML, AND THE LENGTH OF INFUSION HAD BEEN 46 HOURS. THE AIR DETECTOR HAD BEEN OFF, THE UPSTREAM SENSOR HAD BEEN OFF, AND THE LOCK LEVEL HAD BEEN SET TO 2. THE PUMP HAD NOT BEEN USED TO PRIME THE EXTENSION TUBING; THE TUBING HAD BEEN PRIMED MANUALLY. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT AT THE PATIENT'S HOME AND THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766206 CADD ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V 7322 6140818 10610586029646

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown