BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS MEDBANK TWR MN 4HH-4HM-3FM

    MDR report key: 21046436 · Received December 31, 2024

    Report

    Report Number
    2016493-2024-01309
    Event Type
    Malfunction
    Date Received
    December 31, 2024
    Date of Event
    December 3, 2024
    Report Date
    March 5, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512568
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS AND OR ADDITIONAL INFORMATION HAS BEEN ADDED TO THE FOLLOWING SECTIONS: D4, D1, D5, H6, 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 04-DEC-2022 TO 03- DEC-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 DRAWER 7-8 FAILED TO OPEN DUE TO THE MODULE BOARD LIGHT EMITTING DIODE DID NOT LIT AND THAT FAILED IN APPLICATION. A FIELD SERVICE ENGINEER REPLACED THE MODULE BOARD TO RESOLVE THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER TROUBLESHOT THE ISSUE.

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE DRAWER 7-8 FAILED TO OPEN DUE TO MODULE BOARD LEDS NOT LIT AND THAT FAILED IN APPLICATION. A FIELD SERVICE ENGINEER REPLACED THE MODULE BOARD TO RESOLVE THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER TROUBLESHOOTED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PYXIS MEDBANK SYSTEM FAILED TO OPEN AND THIS "MALFUNCTION" AFFECTED ON ISSUING MEDICATION. THE CUSTOMER STATED THAT THE DRAWER DID NOT OPEN TO ISSUE FUROSEMIDE 20MG TAB, LISINOPRIL 5MG TAB AND METOPROLOL TART 25MG TAB. THIS INCIDENT DID NOT CAUSE ANY DELAYS IN PATIENT CARE AND THERE WAS NO PATIENT HARM. HOWEVER, THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PYXIS MEDBANK SYSTEM FAILED TO OPEN AND THIS MALFUNCTION AFFECTED ON ISSUING MEDICATION. THE CUSTOMER STATED THAT THE DRAWER DID NOT OPEN TO ISSUE FUROSEMIDE 20MG TAB, LISINOPRIL 5MG TAB AND METOPROLOL TART 25MG TAB. THIS INCIDENT DID NOT CAUSE ANY DELAYS IN PATIENT CARE AND THERE WAS NO PATIENT HARM. HOWEVER, THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1846928 BD PYXIS MEDBANK TWR MN 4HH-4HM-3FM AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 169-54 10885403512568

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown