BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MEDICATION CASSETTE RESERVOIR

    MDR report key: 22524389 · Received July 16, 2025

    Report

    Report Number
    3012307300-2025-08435
    Event Type
    Malfunction
    Date Received
    July 16, 2025
    Date of Event
    June 8, 2025
    Report Date
    October 15, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10610586032387
    PMA / PMN Number
    K081156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    ONE DEVICE WAS RETURNED FOR ANALYSIS OF COMPLAINT THAT CASSETTE BLOCKS THE FLOW OF LIQUID. AS RECEIVED NO DAMAGE OR ANOMALIES WERE OBSERVED. IN ATTEMPTS TO REPLICATE CLINICAL USE A BLUE CLIP WAS ATTACHED TO THE CASSETTE AND FILLED WITH 250 ML OF WATER USING A MANUFACTURER PROVIDED SYRINGE AND INSERTED INTO A CADD SOLIS PUMP. THE SET WAS PRIMED WITH 10 ML. NO ALARMS, LEAKAGE OR DIFFICULTIES PRIMING WERE OBSERVED. THE COMPLAINT OF CASSETTE BLOCKS FLOW OF FLUID CANNOT BE REPLICATED OR CONFIRMED.

    Description of Event or Problem · 0

    IT WAS SATED THAT THE CASSETTE BLOCKS THE FLOW OF LIQUID. THE INCIDENT OCCURRED BEFORE USE ON THE PATIENT, SPECIFICALLY AT THE TIME OF THE CASSETTE CHANGE. IT HAD NO CLINICAL CONSEQUENCES FOR THE PATIENT. THE TWO AFFECTED CASSETTES WERE RETRIEVED BY THE HOSPITAL PHARMACY (PUI), AND ADDITIONALLY, 4 BOXES CONTAINING 12 UNITS EACH HAVE BEEN PLACED IN QUARANTINE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151600 CADD MEDICATION CASSETTE RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 4434740 10610586032387

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown