BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PYXIS¿ MEDSTATION¿ 4000 INTEGRATED MAIN

    MDR report key: 14286722 · Received May 5, 2022

    Report

    Report Number
    2016493-2022-99071
    Event Type
    Injury
    Date Received
    May 5, 2022
    Date of Event
    April 4, 2022
    Report Date
    February 28, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512629
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED A CAROUSEL DRAWER MISPOCKETED ON A MEDSTATION 4000 DEVICE. THE NURSE WAS ATTEMPTING TO DISPENSE MORPHINE, BUT ALLEGED THAT THE MISPOCKET RESULTED IN THE POCKET OPENING TO VECURONIUM . VECURONIUM WAS ADMINISTERED TO THE PATIENT. THE CUSTOMER DID NOT PROVIDE ANY INFORMATION ON MEDICATION VERIFICATION STEPS PRIOR TO ADMINISTRATION. THE PATIENT HAD TO BE INTUBATED TO MAINTAIN BREATHING IN THE SHORT TERM. THE CUSTOMER CONFIRMED THAT THE PATIENT IS NO LONGER INTUBATED AND CAN EAT AND SIT UP ON HIS OWN. THIS EVENT IS RECORDED IN COMPLAINT NUMBER (B)(4). A BD FIELD SERVICE TECHNICIAN EVALUATED THE DEVICE AND COULD NOT DUPLICATE THE ALLEGED EVENT. A REPORT WAS RUN ON THE DEVICE AND SHOWED NO DRAWER FAILURES OCCURRED IN THE SUSPECTED TIME FRAME OF THE EVENT. THE DRAWER HAS BEEN RETURNED TO THE MANUFACTURING SITE IN (B)(4). AFTER AN ANALYSIS IS PERFORMED, IF NEW INFORMATION IS DISCOVERED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    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 (B)(6) WAS PERFORMED FROM (B)(6) 2020 TO (B)(6) 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 CAROUSEL DRAWER MIS- POCKETED WHEN USER PULLED THE MEDICATION DUE TO MEDICATION JAM WHICH HAD THE POTENTIAL TO INTERFERE WITH THE CAROUSEL POSITION SENSOR. THE FIELD SERVICE ENGINEER REPLACED THE O- RING AS A PREVENTIVE MEASURE FOR ANY PROBLEMS. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER TROUBLESHOT THE DEVICE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED A CAROUSEL DRAWER MISPOCKETED ON A MEDSTATION 4000 DEVICE. THE NURSE WAS ATTEMPTING TO DISPENSE MORPHINE, BUT ALLEGED THAT THE MISPOCKET RESULTED IN THE POCKET OPENING TO VECURONIUM . VECURONIUM WAS ADMINISTERED TO THE PATIENT. THE CUSTOMER DID NOT PROVIDE ANY INFORMATION ON MEDICATION VERIFICATION STEPS PRIOR TO ADMINISTRATION. THE PATIENT HAD TO BE INTUBATED TO MAINTAIN BREATHING IN THE SHORT TERM. THE CUSTOMER CONFIRMED THAT THE PATIENT IS NO LONGER INTUBATED AND CAN EAT AND SIT UP ON HIS OWN.

    Description of Event or Problem · 0

    CUSTOMER REPORTED A CAROUSEL DRAWER MISPOCKETED ON A BD PYXIS¿ MEDSTATION¿ 4000 INTEGRATED MAIN DEVICE. THE NURSE WAS ATTEMPTING TO DISPENSE MORPHINE, BUT ALLEGED THAT THE MISPOCKET RESULTED IN THE POCKET OPENING TO VECURONIUM . VECURONIUM WAS ADMINISTERED TO THE PATIENT. THE CUSTOMER DID NOT PROVIDE ANY INFORMATION ON MEDICATION VERIFICATION STEPS PRIOR TO ADMINISTRATION. THE PATIENT HAD TO BE INTUBATED TO MAINTAIN BREATHING IN THE SHORT TERM. THE CUSTOMER CONFIRMED THAT THE PATIENT IS NO LONGER INTUBATED AND CAN EAT AND SIT UP ON HIS OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1692337 BD PYXIS¿ MEDSTATION¿ 4000 INTEGRATED MAIN AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 306 10885403512629

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention