BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 12737643 · Received November 2, 2021

    Report

    Report Number
    3012307300-2021-10559
    Event Type
    Malfunction
    Date Received
    November 2, 2021
    Report Date
    February 2, 2022
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586019647
    PMA / PMN Number
    K982836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: ADDITIONAL INFORMATION: H10: INFORMATION WAS RECEIVED ON 6-JAN-2-22 INDICATING SERIAL NUMBERS OF PUMPS AND LOT NUMBERS OF CADD CASSETTES INVOLVED. IT WAS NOT INDICATED WHICH CADD PUMP AND WHICH CADD CASSETTE WERE USED IN THE EVENT. THE SERIAL NUMBERS FROM THE PUMPS THAT HAD ISSUES WERE SN: (B)(6). CADD LEGACY PLUS. THE LOT NUMBERS AND EXPIRATION DATES ON THE CADD CASSETTES WERE PRODUCT: 21-7302-24, LOT 4095686, EXPIRATION DATE: 1/21/2026 AND PRODUCT 21-7302-24, LOT 4122832, EXPIRATION DATE: 4/11/2026.

    Additional Manufacturer Narrative · 1

    ADDITIONAL CONTACT: (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT WHILE IN USE OF A SMITHS MEDICAL CADD LEGACY PLUS PUMP, A NO DISPOSABLE PUMP WON'T RUN ALARM WAS NOTED BEFORE THE MEDICATION WAS COMPLETELY INFUSED. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1636177 CADD PUMP, INFUSION FRN ST PAUL 6500 10610586019647

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown