BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

    MDR report key: 24492918 · Received March 3, 2026

    Report

    Report Number
    2016493-2026-10454
    Event Type
    Malfunction
    Date Received
    March 3, 2026
    Date of Event
    February 5, 2026
    Report Date
    March 5, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533235
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES. 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. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(6) WAS PERFORMED FROM THE DATE OF MANUFACTURE, 06-NOV-2017 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 KETAMINE DISPENSED IN THE EMERGENCY DEPARTMENT. A TECHNICAL SUPPORT SPECIALIST EXPLAINED THAT THE ISSUE OCCURRED BECAUSE THE PYXIS MEDICATION DISPENSING SYSTEM LINKED ONLY ONE SYRINGE TO ONE MEDICATION ORDER, AS DOCUMENTED IN THE USER GUIDE ON PAGES 44 THROUGH 45 AND 59 THROUGH 60 AND STATED THAT THE ACTUAL WORKFLOW INVOLVED USING A SINGLE FIFTY MILLIGRAM SYRINGE TO SATISFY MULTIPLE MEDICATION ORDERS OF TWENTY MILLIGRAMS PLUS TEN MILLIGRAMS PLUS TEN MILLIGRAMS, A PROCESS THE SYSTEM WAS NOT DESIGNED TO TRACK ACCORDING TO THE GUIDANCE ON PAGE 42 OF THE USER GUIDE AND FURTHER CLARIFIED THAT SELECTING THE MULTI DOSE OPTION DID NOT RESOLVE THE PROBLEM BECAUSE PREFILLED SYRINGES WERE NOT TREATED AS TRUE MULTI DOSE ITEMS UNLESS SPECIFICALLY CONFIGURED IN THAT MANNER, AS DESCRIBED IN THE HOW IT WORKS GUIDE ON APPROXIMATELY PAGES ONE HUNDRED TEN THROUGH ONE HUNDRED TWELVE. AS A RESULT, THE PYXIS SYSTEM CALCULATED AN EXPECTED WASTE OF THIRTY MILLIGRAMS EVEN THOUGH THE ACTUAL WASTE WAS TEN MILLIGRAMS AND ADVISED THAT THE CUSTOMER COULD EITHER CREATE A DEDICATED ITEM LABELED KETAMINE FOR SEDATION FIFTY MILLIGRAM SYRINGE TO ALLOW A SINGLE REMOVAL COVERING MULTIPLE DOSES OR USE A PATIENT LEVEL KIT OR PROCEDURE-USE WORKFLOW SO THAT ONE SYRINGE COULD APPROPRIATELY SUPPORT ALL REQUIRED DOSES. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST INSPECTED THE ISSUE.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES AUXILIARY, STATION PROVIDED AN EXCESS AMOUNT OF THE DRUG. PATIENTS REQUIRED SMALLER DOSES, AND CUSTOMER WERE ABLE TO UTILIZE A SINGLE SYRINGE TO ACCOMMODATE ALL THEIR DOSES. FOR DOCUMENTATION OF WASTE, THE PYXIS MACHINE REQUIRED A ONE-SYRINGE-TO-ONE-ADMINISTRATION CONFIGURATION AT THAT POINT. CUSTOMER STATED THAT AN ORDER WAS PLACED FOR 20 MG, 50 MG WAS PULLED, AND 30 MG WAS WASTED, SIMILARLY TOTAL OF 40 MG WAS GIVEN FROM TWO SEPARATE ORDERS, IN THAT 50 MG WAS PULLED, AND 10 MG WAS WASTED. TRIED TO CORRECT THE PROBLEM BY CHECKING THE MULTI-DOSE BOX AS HIGHLIGHTED BELOW, BUT THE ISSUE PERSISTED. THE CUSTOMER STATED THAT THERE WAS A DELAY IN PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES AUXILIARY, STATION PROVIDED AN EXCESS AMOUNT OF THE DRUG. PATIENTS REQUIRED SMALLER DOSES, AND CUSTOMER WERE ABLE TO UTILIZE A SINGLE SYRINGE TO ACCOMMODATE ALL THEIR DOSES. FOR DOCUMENTATION OF WASTE, THE PYXIS MACHINE REQUIRED A ONE-SYRINGE-TO-ONE-ADMINISTRATION CONFIGURATION AT THAT POINT. CUSTOMER STATED THAT AN ORDER WAS PLACED FOR 20 MG, 50 MG WAS PULLED, AND 30 MG WAS WASTED, SIMILARLY TOTAL OF 40 MG WAS GIVEN FROM TWO SEPARATE ORDERS, IN THAT 50 MG WAS PULLED, AND 10 MG WAS WASTED. TRIED TO CORRECT THE PROBLEM BY CHECKING THE MULTI-DOSE BOX AS HIGHLIGHTED BELOW, BUT THE ISSUE PERSISTED. THE CUSTOMER STATED THAT THERE WAS A DELAY IN 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
    554150 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002502 10885403533235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown