BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 13967233 · Received March 31, 2022

    Report

    Report Number
    3012307300-2022-05648
    Event Type
    Malfunction
    Date Received
    March 31, 2022
    Date of Event
    January 11, 2022
    Report Date
    March 31, 2022
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    (1/6, REFERENCE (B)(6) FOR RELATED COMPLAINTS) (DOCUMENTING CASSETTE 1). PER CUSTOMER COMPLAINT FORM: PATIENT'S WIFE REPORTS PATIENT HAS HAD 6 CASSETTES THAT BECAME UNUSABLE WITH NO DISPOSABLE PUMP ALARMS AFTER BEING USED FOR SEVERAL HOURS. TROUBLESHOOTING DID NOT RESOLVE THE ISSUE AND A NEW CASSETTE HAD TO BE MIXED AND CHANGED EARLY EACH TIME. PATIENT'S SON DISCARDED 3 CASSETTES, NOT KNOWING THEY NEEDED TO BE CALLED IN. THE THREE REMAINING CASSETTES ARE LOT NUMBERS 4146497 EXPIRATION DATE 2026-05-23, 4189440 EXPIRATION DATE 2026-09-04, AND 4189440 EXPIRATION DATE 2026-09-04. ISSUE TOOK PLACE BETWEEN 12/22/2021-1/11/2022. NO FURTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842976 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown