BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 25066016 · Received May 4, 2026

    Report

    Report Number
    2016493-2026-25519
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    February 14, 2025
    Report Date
    April 30, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    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

    A REVIEW OF THE COMPLAINT HISTORY FOR S/N (B)(6) WAS PERFORMED IN SALESFORCE WHICH DID NOT LOCATE SIMILAR COMPLAINT WITH THE SAME FAILURE MODE FOR THIS SERIAL NUMBER. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR SERIAL NUMBER (B)(6), COVERING THE MANUFACTURING PERIOD BEGINNING ON 25OCT2021 TO THE PRESENT DATE, WAS CONDUCTED. THE REVIEW CONFIRMED THAT NO MANUFACTURING NONCONFORMANCES OR PRODUCTION-RELATED FAILURES WERE IDENTIFIED THAT CORRELATE WITH THE CUSTOMER RE PORTED ISSUE. THE REPORTED CONDITION OF "DEVICE NOT DETECTED ON BUS" WAS CONFIRMED DURING FSE TESTING AND SUBSEQUENTLY CONFIRMED IN THE DCHU TESTING PROCESS. THE DEVICE WAS INITIALLY EVALUATED BY THE FIELD SERVICE ENGINEER (FSE) ACCORDING TO WORK ORDER (B)(4), THE FSE REPORTED THAT DRAWER 2, HALF HEIGHT CUBIE, BOTH DRAWERS NOT DETECTED ON BUS AND NO LIGHTS ON DRAWER. TESTED DRAWER CONTROL PCBS WITH DIGITAL MULTI METER AND DETERMINED DRAWER CONTROL BOARD FOR DRAWER 2.1 WAS BAD AND REPLACED. NO LEDS ON INTERFACE PCB, REPLACED. DRAWER NOW POWERED UP BUT WOULD NOT SENSE CLOSED. REPLACED LATCH SENSOR. DRAWER WOULD STILL NOT CONFIGURE IN MEDSTATION SOFTWARE. REPLACED RETRACTOR BAND. POSITION SENSOR CONNECTION WAS DAMAGED DURING REPLACEMENT OF CONTROL PCB, REPLACED POSITION SENSOR. DURING DCHU VISUAL INSPECTION P/N 353844-01: WAS RECEIVED WITH COPPER STRANDS IN CONTACT WITH ADJACENT COPPER STRANDS. P/N 151622-01: THE PART RECEIVED SHOWED NO SIGNS OF PHYSICAL DAMAGE, FLUID INGRESS, LOOSE OR MISSING COMPONENTS. P/N 151630-01: THE PART RECEIVED SHOWED NO SIGNS OF PHYSICAL DAMAGE, FLUID INGRESS, LOOSE OR MISSING COMPONENTS. P/N 151612-11: THE PART WAS RECEIVED WITH A WIRE DISCONNECTED FROM ITS CONNECTOR HOUSING. P/N 353949-01: THE PART RECEIVED SHOWED NO SIGNS OF PHYSICAL DAMAGE, FLUID INGRESS, LOOSE OR MISSING COMPONENTS. DURING DCHU TESTING P/N 353844-01: THE TESTING FROM DCHU WAS NOT NECESSARILY DUE TO THE THERMAL DAMAGE OBSERVED ON COPPER STRANDS DURING THE VISUAL INSPECTION. P/N 151622-01: FAILED THE DMM TESTING DUE TO LOW RESISTANCE BETWEEN TP502 AND TP505. P/N 151630-01: FAILED THE DMM TESTING DUE TO OPEN FUSE F201. P/N 151612-11: FURTHER TESTING WAS NOT REQUIRED DUE TO PHYSICAL DAMAGE OBSERVED. P/N 353949-01: FAILED THE HTA TESTING DUE TO THE DRAWER WAS NOT ABLE TO OPEN. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, THE DRAWERS 2.1 AND 2.2 WERE NOT DETECTED ON BUS, WHICH LOCATED ON KISK6T2. THE CUSTOMER ATTEMPTED TO REBOOT THE STATION, BUT THE ISSUE PERSISTED. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THERE WAS THERMAL DAMAGE OBSERVED ON THE COPPER STRANDS. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413436 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown