BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 11779315 · Received May 5, 2021

    Report

    Report Number
    3012307300-2021-03873
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    April 7, 2021
    Report Date
    March 22, 2023
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL B10010116, AS A RESULT OF WARNING LETTER CMS#617147. NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DEVICE HISTORY RECORD REVIEW. NO PRODUCT SAMPLE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED AS NO PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    INFORMATION RECEIVED A SMITHS MEDICAL AMBULATORY INFUSION PUMPS/CADD CASSETTE RESERVOIRS - FLOW STOP HAS ALARMS OF CASSETTES NOT ATTACHED. THIS WAS FOUND TO BE ISOLATED TO CASSETTE AND NOT NOT PUMP. IN ONE INSTANCE IT WAS PUMP RELATED OUT OF SIX OCCURRENCES. THE PROBLEM IS BEING ISOLATED TO EF 21-7302-24 100ML CADD LOT: 4092491 CASSETTE. WHEN CHANGING TO NEW ONE THE ISSUE WAS RESOLVED. NO CLINICAL ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676823 CADD ADMINISTRATION SETS FPA ST PAUL 21-7302-24 4092491 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown