BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDFLEX 1000

    MDR report key: 22557660 · Received July 21, 2025

    Report

    Report Number
    2016493-2025-98607
    Event Type
    Malfunction
    Date Received
    July 21, 2025
    Date of Event
    June 24, 2025
    Report Date
    August 27, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512704
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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

    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 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, 16-SEP-2015 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 SYSTEM DISPLAYED A NOTIFICATION TO CONTACT THE DIRECTOR OF NURSING (DON) DUE TO THE INABILITY TO PERFORM A CYCLE COUNT FOR THE ITEM, AND THE QOH REMAINED AT ZERO. A TECHNICAL SUPPORT SPECIALIST (TSS) REMOTELY ACCESSED THE CABINET AND VERIFIED THAT THE ITEM COULD NOT BE ISSUED BECAUSE OF THE ZERO QOH AND THE SYSTEM PROMPT TO NOTIFY THE DON. THE TSS ADVISED THE CUSTOMER TO CONTACT THE DON, WHO HAD FACILITY ADMINISTRATOR ACCESS, TO RESOLVE THE ISSUE. THE CUSTOMER ACKNOWLEDGED THE INSTRUCTIONS. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDFLEX 1000, IT HAD A KEYS LOCKED OUT AND USER STATED THAT ITEM IS SHOWING AS 0 QOH THUS THEY CANNOT ISSUE THE ITEM.. THE CUSTOMER REPORTED THAT 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¿ MEDFLEX 1000, IT HAD A KEYS LOCKED OUT AND USER STATED THAT ITEM IS SHOWING AS 0 QOH THUS THEY CANNOT ISSUE THE ITEM.. THE CUSTOMER REPORTED THAT 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
    2752387 BD PYXIS¿ MEDFLEX 1000 AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500004502000 10885403512704

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown