BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDBANK MINI

    MDR report key: 22642304 · Received July 29, 2025

    Report

    Report Number
    2016493-2025-100960
    Event Type
    Malfunction
    Date Received
    July 29, 2025
    Date of Event
    July 3, 2025
    Report Date
    July 31, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403517181
    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

    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, 11-MAR-2025 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 ITEMS WERE OVERRIDDEN. A TECHNICAL SUPPORT SPECIALIST CONTACTED FOR INVESTIGATION, BUT NO INFORMATION WAS PROVIDED BY THE CUSTOMER AND DECIDED TO CLOSE THE COMPLAINT FILE AS NO RESPONSE FROM THE CUSTOMER END.

    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 BY THE CUSTOMER THAT WHEN USING THE BD PYXIS¿ MEDBANK MINI, ALL ITEMS ARE SET AS GENERAL OVERRIDE EXCEPT THE KEYS WHICH ARE SET TO HIGH ALERT ON THE VITAS MSR DB IN MQL. THIS DB IS SUPPOSED TO PUSH OUT THE ITEMS FORMULARY TO ALL PRX1, PRX2, AND PRX22 VITAS SITES, SO THEIR ITEM FORMULARY MIRRORS THE VITAS MSR, AND IT WAS NOTICED THE VITAS PALMETTO SITE HAD MULTIPLE ITEMS SET AS HIGH ALERT WHICH DID NOT MIRROR THE VITAS MSR DB. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY IN DISPENSING THE MEDICATIONS TO THE PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED DUE TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE BD PYXIS¿ MEDBANK MINI, ALL ITEMS ARE SET AS GENERAL OVERRIDE EXCEPT THE KEYS WHICH ARE SET TO HIGH ALERT ON THE VITAS MSR DB IN MQL. THIS DB IS SUPPOSED TO PUSH OUT THE ITEMS FORMULARY TO ALL PRX1, PRX2, AND PRX22 VITAS SITES, SO THEIR ITEM FORMULARY MIRRORS THE VITAS MSR, AND IT WAS NOTICED THE VITAS PALMETTO SITE HAD MULTIPLE ITEMS SET AS HIGH ALERT WHICH DID NOT MIRROR THE VITAS MSR DB. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY IN DISPENSING THE MEDICATIONS TO THE PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1267460 BD PYXIS¿ MEDBANK MINI AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500004500500 10885403517181

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown