BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDBANK TOWER

    MDR report key: 23691082 · Received December 2, 2025

    Report

    Report Number
    2016493-2025-139795
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Date of Event
    November 10, 2025
    Report Date
    April 10, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512568
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H MANUFACTURER NARRATIVE. THE REPORT OF THE DRAWER DID NOT OPEN WAS CONFIRMED DURING FSE TESTING AND SUBSEQUENTLY VALIDATED IN THE DCHU TESTING PROCESS. THE DEVICE WAS INITIALLY EVALUATED BY THE FIELD SERVICE ENGINEER (FSE) ACCORDING TO WORK ORDER (B)(4), THE FSE REPORTED THAT HALF HEIGHT MINI DRAWERS 1 AND 2 FAILED AND NOT OPENING. THE FSE FOUND NO LIGHTS ON THE MODULE CONTROLLER AND REPLACED THE MODULE CONTROLLER AND HAD MEDBANK REMOTE IN AND CONFIGURE THE DRAWERS. DRAWERS WERE TESTED AND FUNCTIONING PROPERLY. DURING DCHU VISUAL INSPECTION: P/N 151730 21: THE LABORATORY INSPECTION CONFIRMED THAT THE PCBA FH CUBIE PMC SUFFERED A THERMAL DAMAGE. DURING DCHU TESTING: P/N 151730 21: NO FURTHER LABORATORY TEST WAS REQUIRED DUE TO THE VISIBLE DAMAGE OBSERVED DURING THE EXTERNAL INSPECTION. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198 (D). ROOT CAUSE: THE ROOT CAUSE OF THE REPORTED ISSUE DRAWER DID NOT OPEN WAS IDENTIFIED AS A FAULTY PCBA PMC PYXIS MINI FW1 12 DUE TO THERMAL DAMAGE SUFFERED ON COMPONENTS U500 AND C501, WHICH COMPROMISES THE PROPER FUNCTIONALITY OF THE WHOLE BOARD.

    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, 10-FEB-2021 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 IN THIS INCIDENT. IT WAS DETERMINED THAT THE DRAWER DID NOT OPEN. A FIELD SERVICE ENGINEER (FSE) FOUND NO LIGHTS ON THE MODULE CONTROLLER. FSE REPLACED THE MODULE CONTROLLER AND HAD MEDBANK REMOTE IN AND CONFIGURE THE DRAWERS. FSE TESTED A DRAWER AND FUNCTIONING PROPERLY. 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¿ MEDBANK TOWER, THE DRAWER DID NOT OPEN. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THERE WAS THERMAL DAMAGE OBSERVED ON THE PCBA PMC PYXIS MINI FW1 12. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION. HOWEVER, THERE WERE NO DELAYS 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¿ MEDBANK TOWER, THE DRAWER DID NOT OPEN. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION. HOWEVER, THERE WERE NO DELAYS OR ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1912112 BD PYXIS¿ MEDBANK TOWER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500004500000 10885403512568

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown