BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 10222711 · Received July 2, 2020

    Report

    Report Number
    3012307300-2020-06553
    Event Type
    Malfunction
    Date Received
    July 2, 2020
    Report Date
    August 18, 2020
    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

    RETURNED DEVICE WAS RECEIVED IN GOOD PHYSICAL CONDITION. NO EVIDENCE OF REPORTED PROBLEM IN EVENT LOG WAS FOUND. DURING THE EVALUATION OF THE DEVICE, ACCURACY TESTING WAS FOUND TO ALL BE WITHIN SPECIFICATIONS. FLUID INGRESSIONS WERE FOUND IN THE CHASSIS BASE OF THE EXPULSOR. THE DOWNSTREAM AND UPSTREAM OCCLUSION ALARMS WERE ALSO FOUND TO BE BENT AND CRACKED AS WELL AS THE ADMINISTRATION CASSETTE SLOT IN THE CHASSIS. HOWEVER, NO FAULT WAS FOUND WITH THE PUMP WORKING. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT.

    Description of Event or Problem · 0

    ORACLE RO 1072006: FAIL ACCURACY - 8.6 %. ADDITIONAL INFORMATION RECEIVED ON 26-JUN-2020: NO PATIENT INVOLVEMENT. EVENT DETAILS UPDATED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT CADD LEGACY 1 PUMP FAILED ACCURACY BY -8.6%. THERE WAS NO PATIENT INVOLVED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687809 CADD PUMP, INFUSION FRN ST PAUL 21-6400-51 10610586019548

    Patients

    Seq Age Sex Outcome Treatment
    1