BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PYXIS MEDSTATION ES

    MDR report key: 19982066 · Received August 14, 2024

    Report

    Report Number
    2016493-2024-00492
    Event Type
    Injury
    Date Received
    August 14, 2024
    Date of Event
    July 19, 2024
    Report Date
    March 19, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    501

    Narratives

    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: B1, B2, D1, E3, G1, AND H6. 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 20-JUL-2022 TO 19- JUL-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. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT IT WAS DETERMINED THAT THE HINGE SPRING IN THE POCKET PROTRUDED THROUGH THE CRACKED CORNER, LEFT A SHARP WIRE EXPOSED. A FIELD SERVICE ENGINEER REPLACED THE BROKEN CUBIE POCKETS TO RESOLVE THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER TROUBLESHOT THE DEVICE.

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT IT WAS DETERMINED THAT THE SPRING OF THE HINGE IN POCKET WAS STICKING OUT OF THE CRACKED CORNER WHICH RESULTED IN A SHARP WIRE POKING OUT. A FIELD SERVICE ENGINEER REPLACED THE AFFECTED POCKETS TO RESOLVE. THE SYSTEM WAS FUNCTIONAL AS INTENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS MEDSTATION ES SYSTEM SHARP EDGE CUT THE NURSE HAND ACROSS 3 FINGERS WHEN ATTEMPTED TO REMOVE MEDICATIONS FROM POCKET. CUSTOMER STATED THAT WHEN THE NURSE WAS REMOVING MEDICATIONS, THE POCKET DID NOT OPEN, HENCE THE NURSE TAPPED ON THE DRAWER AND SWIPED ACROSS THE POCKETS TO GET IT OPENED WHICH RESULTED A CUT ON FINGERS. THE NURSE HAD TO LEAVE HIS SHIFT FOR THE DAY AS HE REQUIRED A MEDICAL GLUE TO TREAT THE CUT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A PYXIS MEDSTATION ES SYSTEM SHARP EDGE CUT THE NURSE HAND ACROSS 3 FINGERS WHEN ATTEMPTED TO REMOVE MEDICATIONS FROM POCKET. CUSTOMER STATED THAT WHEN THE NURSE WAS REMOVING MEDICATIONS, THE POCKET DID NOT OPEN, HENCE THE NURSE TAPPED ON THE DRAWER AND SWIPED ACROSS THE POCKETS TO GET IT OPENED WHICH RESULTED A CUT ON FINGERS. THE NURSE HAD TO LEAVE HIS SHIFT FOR THE DAY AS HE REQUIRED A MEDICAL GLUE TO TREAT THE CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233912 BD PYXIS MEDSTATION ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O