BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD ADMINISTRATION SET WITH FLOW STOP

    MDR report key: 13759927 · Received March 14, 2022

    Report

    Report Number
    3012307300-2022-04514
    Event Type
    Malfunction
    Date Received
    March 14, 2022
    Date of Event
    January 11, 2022
    Report Date
    March 25, 2022
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Removal / Correction Number
    MW5106710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: 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.

    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.

    Description of Event or Problem · 0

    PER MEDWATCH MW5106710, IT WAS REPORTED THAT CADD ADMINISTRATION SET ALARMED NO CASSETTE. NO PATIENT INJURY REPORTED.ADDITIONAL INFORMATION RECEIVED BY ICU MEDICAL ON 3/1/2022: PATIENT INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    PER MEDWATCH MW5106710, IT WAS REPORTED THAT CADD ADMINISTRATION SET ALARMED NO CASSETTE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1953136 CADD ADMINISTRATION SET WITH FLOW STOP SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 4220003 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female