BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ CII SAFE

    MDR report key: 21808864 · Received April 9, 2025

    Report

    Report Number
    2016493-2025-72100
    Event Type
    Malfunction
    Date Received
    April 9, 2025
    Date of Event
    March 13, 2025
    Report Date
    April 9, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    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

    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, 28-MAR-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 LETTER 'F' ON THE KEYBOARD KEPT JAMMING DUE TO A LOOSE KEY, AND THE DOOR PRODUCED A CLICKING NOISE. A FIELD SERVICE ENGINEER REPLACED THE LATCH IN DOOR 3 AND THE KEYBOARD 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 A BD PYXIS¿ CII SAFE, THE LETTER 'F' ON THE KEYBOARD KEPT JAMMING, AND THERE WAS ALSO A DOOR CLICKING NOISE THE CUSTOMER STATED THAT THIS MALFUNCTION DID NOT CAUSE A DELAY IN DISPENSING MEDICATION TO PATIENTS. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1420648 BD PYXIS¿ CII SAFE AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 111-215

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown