BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYXISES REF 13CF, LHG-3DEEP,9STDBINS

    MDR report key: 23424029 · Received October 30, 2025

    Report

    Report Number
    2016493-2025-128231
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    June 24, 2024
    Report Date
    October 4, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403510434
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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, 07-NOV-2022 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 MESSAGE INDICATING NOT ENOUGH POWER TO RECOVER APPEARED. A FIELD SERVICE ENGINEER WAS DISPATCHED AND ATTEMPTED TO VERIFY THE CUSTOMER'S ISSUE OF INVERTER POWER LOW, BUT THE MESSAGE ONLY APPEARED WHEN THE BATTERY POWER WAS TURNED ON AND OFF. THE ENGINEER DISCONNECTED ALL POWER, TURNED THE BATTERY OFF, AND VERIFIED ALL CONNECTIONS WERE SECURE. 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 PYXISES REF 13CF, LHG-3DEEP,9STDBINS SYSTEM DISPLAYED A MESSAGE INDICATING NOT ENOUGH POWER TO RECOVER AND EMITTED SMOKE. THERE WERE ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369631 PYXISES REF 13CF, LHG-3DEEP,9STDBINS AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 137558-01 10885403510434

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown