BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 14160062 · Received April 20, 2022

    Report

    Report Number
    3012307300-2022-06686
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Date of Event
    February 18, 2022
    Report Date
    April 20, 2022
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    PER MEDWATCH (MW5107654, REPORT DATE: (B)(6) 2022): SPONTANEOUS CALL CASSETTE MALFUNCTION LOT 416-3625, ERROR "NO DISPOSABLE LINE." PATIENT STATES THAT SAME ERROR HAPPENED TO HER BACK UP PUMP AS WELL, BUT SHE DID A NEW CASSETTE AND SHE IS INFUSING MEDICATION WITH NO ISSUE. PATIENT CURRENTLY HAS 7 CASSETTE. DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PT OR CLINICAL INJURY? NO. NOTE: IT WAS CONFIRMED LOT 416-3625 DOES NOT CORRESPONDED TO ANY ICU/SMITH MEDICAL CASSETTE NUMBER. ADDITIONAL INFORMATION RECEIVED AND ATTACHED BY ICU MEDICAL ON 28/MAR/2022 VIA EMAIL: PATIENT DETAILS UPDATED IN COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1409356 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male