BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 22173142 · Received June 9, 2025

    Report

    Report Number
    2016493-2025-86060
    Event Type
    Malfunction
    Date Received
    June 9, 2025
    Date of Event
    May 15, 2025
    Report Date
    August 13, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION B DESCRIBE EVENT OR PROBLEM AND SECTION H MANUFACTURER NARRATIVE THE REPORT THAT THE MINI DRAWER NOT OPENING PROPERLY WAS CONFIRMED BY THE BD FIELD SERVICE ENGINEER (FSE). ACCORDING TO WORK ORDER (B)(4), THE FIELD SERVICE ENGINEER (FSE) FOUND MAIN MINI DRAWER 2.6 WAS NOT WORKING. CABLES AND CONNECTIONS SHOWED THERMAL DAMAGE, BUT NO SIGNS OF FIRE, SPARKS, OR SMOKE. THE FSE REPLACED THE MINI ENGINE, AND THE ESCORT SUCCESSFULLY ACCESSED AND RECOVERED THE POCKET. THE EXTERNAL INSPECTION REVEALED A CRACKED CABLE ON ASSEMBLY CONTROL UNIT 1X1 (P/N 133456-03), EXPOSING INTERNAL WIRING AND SHOWING THERMAL DAMAGE. CONSEQUENTLY, THE UNIT COULD NOT BE TESTED FURTHER. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D).

    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, 14-MAR-2019 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 STATION'S MAIN DRAWER 2.6 12 POCKETS MINI DRAWER WAS OBSTRUCTED, AND IT WAS UNABLE TO OPEN. THE FIELD SERVICE ENGINEER (FSE) HAD VERIFIED THAT THE MAIN MINI DRAWER 2.6 WAS NON-FUNCTIONAL. UPON INSPECTING CABLES AND CONNECTIONS, VISIBLE THERMAL DAMAGE WAS DETECTED, BUT NO SIGNS OF FIRE, SPARKS, OR SMOKE WERE PRESENT. THE FSE REMOVED AND REPLACED THE MINI ENGINE. DURING A PREVENTATIVE INSPECTION, THE FSE FOUND MAIN DRAWER 5 HAD VISIBLE DAMAGE TO THE RETRACTOR BAND, WHICH WAS SUBSEQUENTLY REMOVED AND REPLACED. 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, THE MAIN DRAWER 2.6 12 POCKETS MINI DRAWER WAS OBSTRUCTED, AND IT WAS UNABLE TO OPEN. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THERE WAS THERMAL DAMAGE OBSERVED ON THE CABLES AND CONNECTIONS. HOWEVER, THERE WERE NO DELAY OR 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, THE MAIN DRAWER 2.6 12 POCKETS MINI DRAWER WAS OBSTRUCTED, AND IT WAS UNABLE TO OPEN. THE FIELD SERVICE ENGINEER REPORTED VISIBLE THERMAL DAMAGE WAS FOUND DURING THE INSPECTION. HOWEVER, THERE WERE NO DELAY OR ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1632495 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown