BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 14191602 · Received April 25, 2022

    Report

    Report Number
    3012307300-2022-06911
    Event Type
    Malfunction
    Date Received
    April 25, 2022
    Date of Event
    December 21, 2021
    Report Date
    August 4, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED. WE ARE UNABLE TO CONFIRM THE REPORTED COMPLAINT. IF THE PRODUCT IS RETURNED, SMITHS MEDICAL WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. A DEVICE HISTORY REVIEW WAS ALSO CONDUCTED ON THE COMPONENT LOT NUMBERS AND NO DISCREPANCIES WERE FOUND.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: D4: CORRECTION: DEVICE EXPIRATION DATE: 2-SEP-2026 D1: CORRECTION: BRAND NAME: CADD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT AWAKENED TO NO DISPOSABLE ALARM ON THE PUMP. WALKED PATIENT THROUGH RESEATING THE CASSETTE ON PUMP AND ONCE PUMP RESTARTED, IT BEGAN ALARMING AGAIN PLUS HAD A TWO-TONE BEEP THAT WOULD NOT STOP. AFTER SWITCHING SAME CASSETTE, LOT# 4192062, EXP 9/2/26, TO BACK UP PUMP, THE ALARM BEGAN AGAIN. PATIENTS SON-IN-LAW ARRIVED AND THIS RN ASKED HIM TO MIX NEW REMODULIN CASSETTE. ONCE COMPLETED, PUMP RESTARTED AND RECONNECTED TO PATIENT, THE PUMP RAN WITHOUT ALARM. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982691 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 4192062 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown