BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PYXIS ANESTHESIA STATION ES

    MDR report key: 15614699 · Received October 17, 2022

    Report

    Report Number
    2016493-2022-99170
    Event Type
    Injury
    Date Received
    October 17, 2022
    Date of Event
    September 29, 2022
    Report Date
    March 14, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403477836
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED THAT A PYXIS ANESTHESIA ES SYSTEM DRAWER DID NOT RELEASE DURING A PROCEDURE, PREVENTING USER ACCESS TO MEDICATION. PATIENT REPORTED AS UNDERGOING AN ESOPHAGOGASTRODUODENOSCOPY FOR HEMORRHAGE PROCEDURE AND EXPERIENCING LIFE THREATENING ARRYTHMIA. CUSTOMER STATED THAT BETA BLOCKERS AND ANTI ARRHYTHMIC DRUGS WERE THE REQUIRED MEDICATION. CUSTOMER REPORTED A DELAY TO CARE OF SEVERAL MINUTES. THE REQUIRED MEDICATION WAS OBTAINED BY USING THE DRAWER'S KEYS. CUSTOMER REPORTED MEDICAL INTERVENTION WAS NEEDED TO PREVENT PATIENT HARM. THIS EVENT IS RECORDED IN COMPLAINT NUMBER (B)(4). A FIELD SERVICE ENGINEER EVALUATED THE DEVICE AND DETERMINED THAT TWO MINI DRAWER ENGINES WERE JAMMING. THE FIELD SERVICE ENGINEER REPLACED THE DRAWER ENGINES TO RESOLVE. DEVICE CONFIRMED OPERATIONAL.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REGULATORY REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED THROUGH CAPA 10308384. THE LATE SUBMISSION OF THIS SUPPLEMENTAL REPORT IS DUE TO THE THOROUGH AND DETAILED NATURE OF THE RETROSPECTIVE REVIEW PROCESS. THIS PROCESS WAS ESSENTIAL TO ACCURATELY CAPTURE ALL RELEVANT DATA AND ENSURE THE INTEGRITY OF OUR REPORTING. WE HAVE INCLUDED THE CAPA REFERENCE FOR THE RETROSPECTIVE REVIEW IN THE ADDITIONAL MANUFACTURER NARRATIVE SECTION OF THE FDA FORM 3500A, AS RECOMMENDED. THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL/CORRECTED INFORMATION: A1, B1, B5, D1, D4, D5, G1, H1, H6 AND H11. 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 29-SEP-2020 TO 29-SEP-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 MINI ENGINES KEPT JAMMING AFTER THE POWER SWITCH COVER WAS INSTALLED. THE FIELD SERVICE ENGINEER MOVED MEDICATIONS TO DRAWER POCKETS 9 AND 10 TO RESOLVE THE ISSUE, THEY WILL REPLACE THOSE ENGINES WHEN THE ROOM AVAILABLE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT A PYXIS ANESTHESIA ES SYSTEM DRAWER DID NOT RELEASE DURING A PROCEDURE, PREVENTING USER ACCESS TO MEDICATION. PATIENT REPORTED AS UNDERGOING AN ESOPHAGOGASTRODUODENOSCOPY FOR HEMORRHAGE PROCEDURE AND EXPERIENCING LIFE THREATENING ARRYTHMIA. CUSTOMER STATED THAT BETA BLOCKERS AND ANTI ARRHYTHMIC DRUGS WERE THE REQUIRED MEDICATION. CUSTOMER REPORTED A DELAY TO CARE OF SEVERAL MINUTES. THE REQUIRED MEDICATION WAS OBTAINED BY USING THE DRAWER'S KEYS. CUSTOMER REPORTED MEDICAL INTERVENTION WAS NEEDED TO PREVENT PATIENT HARM.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT A BD PYXIS ANESTHESIA ES SYSTEM DRAWER DID NOT RELEASE DURING A PROCEDURE, PREVENTING USER ACCESS TO MEDICATION. PATIENT REPORTED AS UNDERGOING AN ESOPHAGOGASTRODUODENOSCOPY FOR HEMORRHAGE PROCEDURE AND EXPERIENCING LIFE THREATENING ARRYTHMIA. CUSTOMER STATED THAT BETA BLOCKERS AND ANTI ARRHYTHMIC DRUGS WERE THE REQUIRED MEDICATION. CUSTOMER REPORTED A DELAY TO CARE OF SEVERAL MINUTES. THE REQUIRED MEDICATION WAS OBTAINED BY USING THE DRAWER'S KEYS. CUSTOMER REPORTED MEDICAL INTERVENTION WAS NEEDED TO PREVENT PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2943243 BD PYXIS ANESTHESIA STATION ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 327 10885403477836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention