BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

    MDR report key: 25081095 · Received May 5, 2026

    Report

    Report Number
    2016493-2026-26033
    Event Type
    Malfunction
    Date Received
    May 5, 2026
    Date of Event
    November 20, 2025
    Report Date
    April 20, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533235
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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, 12-AUG-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 REPORTED CONDITION OF AUX 3.2 DRAW IS FAILED AND DOES NOT RECOVER WAS CONFIRMED DURING FSE TESTING AND SUBSEQUENTLY CONFIRMED DURING DCHU INVESTIGATION PROCESS. ACCORDING TO WORK ORDER: (B)(4), THE FIELD SERVICE ENGINEER REPORTED THAT DRAWER 3.2 WAS FAILING. AFTER PERFORMING AN INSPECTION, IT WAS FOUND THAT THE BACK KEYBOARD LIGHTS WERE FLICKERING, SO THE RETRACTOR BAND, CONTROLLER CARD, AND KEYBOARD ON BOTH DRAWERS WERE REPLACED. OPERATION WAS THEN VERIFIED WITH THE PHARMACY STAFF. DURING DCHU VISUAL INSPECTION: P/N: 353844-01: THE ASSY RETRACTOR DWR HH CUBIE (A) WAS RECEIVED WITH COPPER STRANDS IN CONTACT WITH ADJACENT COPPER STRANDS WITH ASSOCIATED THERMAL DAMAGE OBSERVED. P/N: 353844-01: THE ASSY RETRACTOR DWR HH CUBIE (B) WAS RECEIVED WITH NO PHYSICAL DAMAGE, THERMAL DAMAGE OR ANY OTHER ANOMALIES WERE DETECTED. P/N: 151622-01: THE PCBA DWR CNTLR V1.10/V1 S/N: (B)(6) SHOWED NO SIGNS OF PHYSICAL DAMAGE, FLUID INGRESS, THERMAL DAMAGE LOOSE OR MISSING COMPONENTS. P/N: 151622-01: THE PCBA DWR CNTLR V1.10/V1 S/N: (B)(6) SHOWED NO SIGNS OF PHYSICAL DAMAGE, FLUID INGRESS, THERMAL DAMAGE, LOOSE OR MISSING COMPONENTS P/N: 151630-01: THE PCBA PMC V1.06/V0.09BL HH S/N: (B)(6) SHOWED NO SIGNS OF PHYSICAL DAMAGE, FLUID INGRESS, THERMAL DAMAGE, LOOSE OR MISSING COMPONENTS. P/N: 151630-01: THE PCBA PMC V1.06/V0.09BL HH S/N: (B)(6) SHOWED NO SIGNS OF PHYSICAL DAMAGE, FLUID INGRESS, THERMAL DAMAGE, LOOSE OR MISSING COMPONENTS. DURING DCHU TESTING P/N: 353844-01: NO DCHU TESTING WAS REQUIRED ASSY RETRACTOR DWR HH CUBIE (A) DUE TO THE THERMAL DAMAGE IDENTIFIED DURING THE VISUAL INSPECTION. P/N: 353844-01: THE ASSY RETRACTOR DWR HH CUBIE (B) PASSED THE DMM AND HTA TESTING WITH NO ANOMALIES OR INTERMITTENCY DETECTED. P/N: 151622-01: THE PCBA DWR CNTLR V1.10/V1 S/N: (B)(6) PASSED SUCCESSFULLY THE DMM AND HTA TESTING WITH NO ANOMALIES OR INTERMITTENCY DETECTED. P/N: 151622-01: THE PCBA DWR CNTLR V1.10/V1 S/N: (B)(6) PASSED SUCCESSFULLY THE DMM AND HTA TESTING WITH NO ANOMALIES OR INTERMITTENCY DETECTED. P/N: 151630-01: THE PCBA PMC V1.06/V0.09BL HH S/N: (B)(6) PASSED SUCCESSFULLY THE DMM AND HTA TESTING WITH NO ANOMALIES OR INTERMITTENCY DETECTED. P/N: 151630-01: THE PCBA PMC V1.06/V0.09BL HH S/N: (B)(6) PASSED SUCCESSFULLY THE DMM AND HTA TESTING WITH NO ANOMALIES OR INTERMITTENCY DETECTED. 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 AUX 3.2 DRAW IS FAILED AND DOES NOT RECOVER. WAS DETERMINED TO BE DUE TO A THERMALLY DAMAGED ASSY RETRACTOR DWR HH CUBIE (A) (P/N: 353844-01) WHICH PREVENTED THE UNIT FROM DRAWER RECOVERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES AUXILIARY, THE DRAWER 3.2 FAILED TO RECOVER, WHICH LOCATED ON NB2CA. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THERE WAS THERMAL DAMAGE OBSERVED ON THE ASSY RETRACTOR DWR HH CUBIE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194378 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002502 10885403533235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown