BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYXIS ANESTHESIA SYSTEM ES

    MDR report key: 18824227 · Received March 4, 2024

    Report

    Report Number
    2016493-2024-00110
    Event Type
    Malfunction
    Date Received
    March 4, 2024
    Date of Event
    March 4, 2024
    Report Date
    February 13, 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
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT IT WAS DETERMINED THAT DRAWER 2-1 FAILED TO OPEN DUE TO A DAMAGED POSITION SENSOR AND RETRACTOR BAND. A FIELD SERVICE ENGINEER REPLACED THE RETRACTOR BAND AND POSITION SENSOR TO RESOLVE; THIS WORK IS RECORDED IN WORK ORDER 01377123. THE SYSTEM FUNCTIONED AS INTENDED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL/CORRECTED INFORMATION: A.1, D.4, G.2, H.6 COMPLAINT HISTORY REVIEW: 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. DEVICE HISTORY RECORD: A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(6) WAS PERFORMED FROM 05-FEB-2022 TO 05-FEB-2024 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING AND THERE WERE NO PRODUCTION FAILURES WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. INVESTIGATION SUMMARY: UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT IT WAS DETERMINED THAT DRAWER 2-1 FAILED TO OPEN DUE TO A POSITION SENSOR, RETRACTOR BAND, AND A POSITION SENSOR WIRE DAMAGED. A FIELD SERVICE ENGINEER REPLACED THE RETRACTOR BAND AND POSITION SENSOR TO RESOLVE FOLLOWED BY PREVENTIVE MAINTENANCE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER TROUBLESHOT THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A PYXIS ANESTHESIA ES SYSTEM DRAWER FAILED TO OPEN, AFFECTING PATIENT CARE. NO OTHER INFORMATION WAS RELEASED REGARDING THE EVENT. 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 PYXIS ANESTHESIA ES SYSTEM DRAWER FAILED TO OPEN AND AFFECTED 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
    695403 PYXIS ANESTHESIA SYSTEM ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 327 10885403477836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown