BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS ANESTHESIA STATION ES SYSTEM

    MDR report key: 18550604 · Received January 22, 2024

    Report

    Report Number
    2016493-2024-00038
    Event Type
    Malfunction
    Date Received
    January 22, 2024
    Date of Event
    December 27, 2023
    Report Date
    March 4, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403477836
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT IT WAS DETERMINED THAT THE STATION GRAYED OUT DUE TO HARDWARE ISSUES. THE DEVICE'S ALL IN ONE COMPUTER AND SOLID-STATE DRIVE WERE REPLACED TO RESOLVE. THE SYSTEM FUNCTIONED AS INTENDED.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THE PRODUCT BREAKS DURING OPERATION. TO AID IN THE INVESTIGATION, TWO HUNDRED TWENTY-FIVE SAMPLES IN SEALED PACKAGING BLISTERS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. EIGHTY SAMPLES WERE RANDOMLY SELECTED FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED WITH 30X MAGNIFICATION. NO DEFECTS, IMPERFECTIONS OR DAMAGES WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305127, LOT 4081101. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A PYXIS ANESTHESIA ES SYSTEM SCREEN DIMS AND LOCKS UP DURING PROCEDURES. THE CUSTOMER ADDED THAT THE ISSUE IS TEMPORARILY RESOLVED BY REBOOTING THE DEVICE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS ANESTHESIA STATION ES SYSTEM TOUCHSCREEN DARKENED AND LOCKED UP DURING PROCEDURE. THE SYSTEM HAD TO BE RESTARTED TO RECOVER TEMPORARILY. THE MALFUNCTION CAUSED A DELAY OF 3 MINUTES IN THE PATIENT WORKFLOW. CUSTOMER REPORTED THAT THIS ISSUE HAD BEEN OCCURRING FREQUENTLY, IMPACTING PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1773638 BD PYXIS ANESTHESIA STATION ES SYSTEM AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 327 10885403477836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown