BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYXISES REF5CF,LHG-3DEEP,3STDBINS,CASTER

    MDR report key: 23434353 · Received October 31, 2025

    Report

    Report Number
    2016493-2025-128484
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    November 26, 2024
    Report Date
    October 17, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403510427
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING JANUARY 2022-DECEMBER 5, 2024, UNDER CAPA 10308384. THE LATE SUBMISSION OF THIS REPORT IS JUSTIFIED BY THE THOROUGH AND DETAILED NATURE OF THE RETROSPECTIVE REVIEW PROCESS. THIS PROCESS WAS ESSENTIAL TO ACCURATELY CAPTURE ALL RELEVANT DATA AND ENSURE THE INTEGRITY OF OUR REPORTING. WE HAVE INCLUDED THE CAPA REFERENCE FOR THE RETROSPECTIVE REVIEW IN THE ADDITIONAL MANUFACTURER NARRATIVE SECTION OF THE FDA FORM 3500A, AS RECOMMENDED. A REVIEW OF THE COMPLAINT HISTORY FOR SN (B)(6) WAS PERFORMED IN SALESFORCE WHICH DID NOT LOCATE SIMILAR COMPLAINTS WITH THE SAME FAILURE MODE FOR THIS SERIAL NUMBER. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(6) WAS PERFORMED FROM THE DATE OF MANUFACTURE, 06-MAY-2020 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING AND THERE WERE NO PRODUCTION FAILURES WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE DEVICE WAS NOT DETECTED ON THE BUS AND THE CUSTOMER STATED THAT DUE TO THE ISSUE THEY WERE REQUIRED TO GET MEDICATION FROM OTHER DEVICES TO PREVENT PATIENT CARE DELAY. A FIELD SERVICE ENGINEER WORKED WITH THE CUSTOMER THROUGH A REBOOT SEQUENCE TO CLEAR THE ES FRIDGE NOT DETECTED ON BUS ERROR. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER TROUBLESHOT THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS REFRIGERATOR WAS NOT DETECTED ON THE BUS AND THE CUSTOMER STATED THAT DUE TO THE ISSUE THEY WERE REQUIRED TO GET MEDICATION FROM OTHER DEVICES TO PREVENT PATIENT CARE DELAY. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1714829 PYXISES REF5CF,LHG-3DEEP,3STDBINS,CASTER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 137731-01 10885403510427

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown