BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 25092032 · Received May 6, 2026

    Report

    Report Number
    2016493-2026-26180
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    December 23, 2025
    Report Date
    April 20, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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, 04-JAN-2021 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING AND THERE WERE NO PRODUCTION FAILURES WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. PART ANALYSIS: THE REPORT CONDITION OF 10ICCEAST PYXIS DOWN - OFFLINE WAS CONFIRMED DURING FSE TESTING AND SUBSEQUENTLY CONFIRMED DURING DCHU INVESTIGATION PROCESS. ACCORDING TO WORK ORDER (B)(4), THE FSE REPORTED THAT MAIN DRAWER HH 2.1 CAUSED NOT POWER ON. THE FSE REPLACED HH PMC, BOTH DRAWERS CONTROL PCBAS AND RETRACTOR BANDS. THE FSE REASSIGNED DRAWERS POSITIONS. HTA TEST PASSED. PHARMACY TECHNICIAN TESTED WITH NO PROBLEMS. DURING DCHU VISUAL INSPECTION: P/N 353844-01: BOTH WERE RECEIVED WITH COPPER STRANDS IN CONTACT WITH ADJACENT COPPER STRANDS AND EXHIBITED THERMAL DAMAGE. P/N 151622-01: BOTH HAD NO MISSING COMPONENTS, SIGNS OF FLUID INGRESS, THERMAL DAMAGE OR ANY PHYSICAL ANOMALY OBSERVED. P/N 151630-01: HAD NO MISSING COMPONENTS, SIGNS OF FLUID INGRESS, THERMAL DAMAGE OR ANY PHYSICAL ANOMALY OBSERVED. DURING DCHU TESTING: P/N 353844-01: THE TESTING FROM DCHU WAS NOT REQUIRED ON BOTH PARTS RECEIVED DUE TO THE THERMAL DAMAGE OBSERVED ON COPPER STRANDS DURING THE VISUAL INSPECTION. P/N 151622-01: DRAWER CONTROLLER BOARD (S/N (B)(6)) WAS EVALUATED ON AN ESD PROTECTED SURFACE WITH A CALIBRATED DMM AND IT PASSED THE RESISTANCE TESTING ON COMPONENTS D501, MOSFET Q501 AND MOSFET Q601. A FUNCTIONAL TESTING WAS PERFORMED USING A DCHU HTA EQUIPMENT AND NO ISSUES OR INTERMITTENCY WERE FOUND. DRAWER CONTROLLER BOARD (S/N (B)(6)) WAS EVALUATED ON AN ESD PROTECTED SURFACE WITH A CALIBRATED DMM AND IT FAILED DURING THE RESISTANCE TESTING ON COMPONENTS D501 AND MOSFET Q501. NO FURTHER TESTING WAS REQUIRED. P/N 151630-01: THE PMC HH WAS EVALUATED ON AN ESD PROTECTED SURFACE WITH A CALIBRATED DMM AND IT PASSED THE RESISTANCE TESTING ON FUSE F201. A FUNCTIONAL TESTING WAS PERFORMED USING A DCHU HTA EQUIPMENT AND NO ISSUES OR INTERMITTENT BEHAVIOR WERE FOUND. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D). ROOT CAUSE: THE ROOT CAUSE OF THE REPORTED ISSUE "10ICCEAST PYXIS DOWN - OFFLINE" WAS DUE TO TWO "ASSY RETRACTOR. DWR HH CUBIE" (P/N 353844-01) WITH CROSSED CONTINUITY BETWEEN ADJACENT COPPER STRANDS WHICH RESULTED ON THERMAL DAMAGE, AND A FAULTY "PCBA DWR CNTLR VL.LO/VL" (P/N 151622- 01; S/N (B)(6)) WITH A DAMAGED D501/MOSFET Q501 DUE TO AN OVERCURRENT CONDITION, THAT PREVENTED THE UNIT FROM POWERING ON.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES SHOWN OFFLINE AND FAILED TO POWER ON, WHICH WAS LOCATED ON 10ICCEAST. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THERE WAS THERMAL DAMAGE OBSERVED DUE TO CROSSED CONTINUITY BETWEEN ADJACENT COPPER STRANDS OF ASSY RETRACTOR. DWR HH CUBIE AND FOUND DAMAGED D501 MOSFET Q501 DUE TO AN OVERCURRENT CONDITION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153998 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown