BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MEDICATION CASSETTES

    MDR report key: 14282932 · Received May 4, 2022

    Report

    Report Number
    3012307300-2022-07530
    Event Type
    Malfunction
    Date Received
    May 4, 2022
    Date of Event
    December 21, 2021
    Report Date
    May 3, 2022
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT OR PHOTOGRAPHIC EVIDENCE WERE PROVIDED TO AID IN THIS INVESTIGATION. THE COMPLAINT REPORT OFFERED INSUFFICIENT DETAILS TO DETERMINE WHETHER THIS PRODUCT FUNCTIONED AS INTENDED, OR WAS USED IN A MANNER CONSISTENT WITH ITS INSTRUCTIONS FOR USE (IFU) OR FAILED TO MEET PRODUCT SPECIFICATIONS. LACKING ANY ADDITIONAL EVIDENCE, THIS COMPLAINT HAS BEEN CLOSED AS UNCONFIRMED. IF THE PRODUCT IS RETURNED, SMITHS MEDICAL WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. A MANUFACTURING DHR REVIEW WAS NOT PERFORMED BECAUSE THE RESULTS OF THE COMPLAINT INVESTIGATION DO NOT INDICATE A PROBLEM WITH THE MANUFACTURE OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WOKE TO A "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 (B)(6) 2026, TO BACK UP PUMP, THE ALARM BEGAN AGAIN. PATIENT SON-IN LAW ARRIVED, AND THIS RN ASKED HIM TO MIX NEW REMODULIN CASSETTE. ONCE COMPLETED, PUMP RESTARTED AND RECONNECTED TO CASSETTE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790581 CADD MEDICATION CASSETTES SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 4192062 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown