BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 14564382 · Received June 1, 2022

    Report

    Report Number
    3012307300-2022-10247
    Event Type
    Malfunction
    Date Received
    June 1, 2022
    Date of Event
    April 25, 2022
    Report Date
    June 1, 2022
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586019548
    PMA / PMN Number
    K982838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT OR PHOTOGRAPHIC EVIDENCE WERE PROVIDED TO AID IN THIS INVESTIGATION. THE COMPLAINT REPORT OFFERED INSUFFICIENT DETAILS TO DETERMINE WHETHER THIS PRODUCT FUNCTIONED AS INTENDED, OR WAS USED IN A MANNER CONSISTENT WITH ITS INSTRUCTIONS FOR USE (IFU) OR FAILED TO MEET PRODUCT SPECIFICATIONS. LACKING ANY ADDITIONAL EVIDENCE, THIS COMPLAINT HAS BEEN CLOSED AS UNCONFIRMED. IF THE PRODUCT IS RETURNED, SMITHS MEDICAL WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. A MANUFACTURING DHR REVIEW WAS NOT PERFORMED BECAUSE THE RESULTS OF THE COMPLAINT INVESTIGATION DO NOT INDICATE A PROBLEM WITH THE MANUFACTURE OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "NO DISPOSABLE" ALARMS OCCURRED ON (B)(6) 2022 WITH BOTH CADD LEGACY PUMP SERIAL NUMBERS (B)(4) AND CADD CASSETTE LOT NUMBER 4220003. EXPIRATION DATE 11/24/2026. CASSETTE WAS PLACED AT 10:30PM AND ALARM OCCURRED APPROXIMATELY 1.5 HOURS LATER. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305064 CADD PUMP, INFUSION FRN ST PAUL 6400 10610586019548

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown