BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

    MDR report key: 23156688 · Received September 26, 2025

    Report

    Report Number
    2016493-2025-118116
    Event Type
    Malfunction
    Date Received
    September 26, 2025
    Date of Event
    September 2, 2025
    Report Date
    October 6, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512681
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES. A REVIEW OF THE COMPLAINT HISTORY FOR SN (B)(6) WAS PERFORMED IN SALESFORCE WHICH DID NOT LOCATE SIMILAR COMPLAINT(S) 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, 31-JAN-2017 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 DRAWER WAS FAILED. A FIELD SERVICE ENGINEER (FSE) IDENTIFIED THAT THE SEA CHANNEL ON THE LEFT SIDE OF DRAWER MODULE FIVE WAS BROKEN. THEN THE FSE WAS ABLE TO PLACE A SPACER TEMPORARILY, SO THE DOOR WILL OPEN AND CLOSE UNTIL A NEW SEA CHANNEL CAN BE ORDERED AND INSTALLED. IT WAS ALREADY DIAGNOSED FROM A PREVIOUS SERVICE VISIT THAT THE SEA CHANNEL OR MODULE FIVE WAS BROKEN. THE FSE REPLACED THE LEFT SIDE C CHANNEL AND THEN TESTED THE DRAWER AFTERWARD FOR PROPER OPERATION. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER REPAIRED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES AUXILIARY, AUXILIARY 5.2 WAS NOT WORKING AND DRAWER NOT OPEN. THE CUSTOMER REPORTED THAT THE ISSUE OCCURRED WHEN DISPENSING MEDICATIONS TO THE PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES AUXILIARY, AUXILIARY 5.2 WAS NOT WORKING AND DRAWER NOT OPEN. THE CUSTOMER REPORTED THAT THE ISSUE OCCURRED WHEN DISPENSING MEDICATIONS TO THE PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2112992 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002502 10885403512681

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown