BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

    MDR report key: 21950240 · Received May 2, 2025

    Report

    Report Number
    2016493-2025-77713
    Event Type
    Malfunction
    Date Received
    May 2, 2025
    Date of Event
    April 7, 2025
    Report Date
    May 2, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512681
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE COMPLAINT HISTORY FOR (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 (B)(6) WAS PERFORMED FROM THE DATE OF MANUFACTURE, 13-APR-2022 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 CUBIES ON D AND C ROWS WERE DISPLAYED READ/WRITE ERRORS. A FIELD SERVICE ENGINEER LOGGED INTO HARDWARE TEST APPLICATION, OPENED AUXILIARY 1.1, POPPED OUT CUBIES AND CLEANED CONNECTIONS WITH ALCOHOL WIPES. REINSERTED CUBIES IN CORRECT LOCATION, POPPED OPEN LIDS. OPENED 1.2 AND POPPED OPEN ALL LIDS THERE ALSO. THEN, THE FIELD SERVICE ENGINEER REBOOTED THE STATION AND RECOVERED FAILED POCKETS TO RESOLVE THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER REPAIRED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES AUXILIARY, THE CUBIES ON D AND C ROWS WERE DISPLAYED READ/WRITE ERRORS. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY IN DISPENSING THE MEDICATIONS TO THE PATIENT, BUT THE USER MANAGED TO RETRIEVE THE MEDICATION FROM ANOTHER DEVICE. HOWEVER, THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209145 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 324 10885403512681

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown