BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDFLEX 1000

    MDR report key: 22162133 · Received June 7, 2025

    Report

    Report Number
    2016493-2025-85817
    Event Type
    Malfunction
    Date Received
    June 7, 2025
    Date of Event
    May 15, 2025
    Report Date
    June 6, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512704
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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, 30-JUL-2018 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 FRIDGE WAS UNABLE TO ISSUE THE MEDICATION. THE TECHNICAL SUPPORT SPECIALIST THAT BIN 02 16, WHICH HAD SET MAXIMUM AND MINIMUM QUANTITIES, WHERE THE QUANTITY ON HAND (QOH) WAS SHOWING AS ZERO. ADVISED THE CUSTOMER TO HAVE AN EMPLOYEE WITH CYCLE COUNT PRIVILEGES UPDATE THE QOH ACCORDINGLY TO RESOLVE THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE BD PYXIS¿ MEDFLEX 1000, THE FRIDGE WAS UNABLE TO ISSUE THE MEDICATION. THE CUSTOMER REPORTED THAT A MALFUNCTION TOOK PLACE WHEN THE USER TRIED TO DISPENSE MEDICATION 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
    1391780 BD PYXIS¿ MEDFLEX 1000 AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 1119-00 10885403512704

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown