BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 13408934 · Received February 1, 2022

    Report

    Report Number
    3012307300-2022-02235
    Event Type
    Malfunction
    Date Received
    February 1, 2022
    Date of Event
    October 1, 2021
    Report Date
    February 1, 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

    THE SERIAL NUMBERS FROM THE PUMPS THAT CUSTOMER HAVE HAD TROUBLE WITH ARE (B)(4). THE LOT NUMBERS AND EXPIRATION DATES ON THE CADD CASSETTES WERE PRODUCT NUMBER 21-7302-24, LOT 4095686, EXPIRATION DATE 1/21/2026 AND PRODUCT NUMBER 21-7302-24, LOT 4122832, EXPIRATION DATE 4/11/2026.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED REGARDING A CADD LEGACY PLUS PUMP. IT WAS REPORTED THAT THE DEVICE HAS BEEN ALARMING BEFORE THE MEDICATION IS COMPLETELY INFUSED. THE ERROR ON THE PUMP WAS "NO DISPOSABLE, PUMP WON'T RUN." THIS OCCURRED ON TWO PUMPS IN THE PAST WEEK. ONE CASSETTE HAD APPROXIMATELY 100ML REMAINING WHEN IT ALARMED. THE OTHER HAD ABOUT 5ML REMAINING. THEY CONTACTED SIMS DELTEC, INC., AND A REPRESENTATIVE STATED THAT THERE HAD BEEN A CHANGE IN THE PRODUCT INVOLVED A FLOW STOP VALVE. ADDITIONAL INFORMATION REPORTED THAT THERE WERE FOUR TOTAL EVENTS, ALL OF WHICH HAD PATIENT INVOLVED. CUSTOMER DID NOT PROVIDE INFORMATION AS TO WHICH PUMP AND CASSETTE WERE USED WITH EACH PATIENT. IT WAS NOTED THAT ONE PATIENT ONLY RECEIVED 61.75ML OF 110ML DOSE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860638 CADD INFUSION PUMP FRN ST PAUL 21-6500-51 10610586019647

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male