BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE RESERVOIR

    MDR report key: 11886217 · Received May 26, 2021

    Report

    Report Number
    3012307300-2021-05089
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Report Date
    May 26, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 1

    POSSIBLE LOT NUMBERS: 4076283, 3739113 AND 4092492. (B)(6). OCCUPATION: PRODUCT COMPLAINT ANALYST.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD CASSETTE RESERVOIR HAS CAUSED AN INCREASE IN "NO DISPOSABLE" ALARMS. IT WAS REPORTED THAT THE REMAINING VOLUME IN THE PUMP WAS ABOUT 83.94ML. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783113 CADD CASSETTE RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1