BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

    MDR report key: 22518551 · Received July 16, 2025

    Report

    Report Number
    2016493-2025-97131
    Event Type
    Malfunction
    Date Received
    July 16, 2025
    Date of Event
    June 19, 2025
    Report Date
    July 23, 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
    OTHER HEALTH CARE PROFESSIONAL
    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

    THE FOLLOWING FIELD HAD BEEN UPDATED WITH ADDITIONAL INFORMATION: H6. 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, 21-FEB-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 PATIENT HAD TWO DIFFERENT BED NUMBERS. A TECHNICAL SUPPORT SPECIALIST REMOTELY DIALED INTO THE STATION, BASED ON THE SAMPLE ENCOUNTER ID, FOUND THAT THERE WERE TWO ADMISSIONS FOR THE PATIENT. THE TECHNICAL SPECIALIST ADVISED THE CUSTOMER TO DELETE THE DUPLICATE ADMISSION RECORD TO RESOLVE THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST ASSESSED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES AUXILIARY, THE PATIENT WITH THE ENCOUNTER NUMBER (1090427) APPEARS TO BE IN PYXIS IN TWO DIFFERENT BED NUMBERS (204B) AND (208A) AND THE PATIENT WAS TRANSFERRED FROM ONE BED TO ANOTHER BUT IN PYXIS IS STILL SEPARATED. THE CUSTOMER STATED THAT THERE WAS NO DELAY, BUT THE MALFUNCTION OCCURRED WHEN THE USER TRIED TO ISSUE MEDICATION TO THE PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED DUE TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES AUXILIARY, THE PATIENT WITH THE ENCOUNTER NUMBER (1090427) APPEARS TO BE IN PYXIS IN TWO DIFFERENT BED NUMBERS (204B) AND (208A) AND THE PATIENT WAS TRANSFERRED FROM ONE BED TO ANOTHER BUT IN PYXIS IS STILL SEPARATED. THE CUSTOMER STATED THAT THERE WAS A DELAY, AND THE MALFUNCTION OCCURRED WHEN THE USER TRIED TO ISSUE MEDICATION TO THE PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129577 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002502 10885403512681

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown