BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 24159911 · Received January 23, 2026

    Report

    Report Number
    2016493-2026-01849
    Event Type
    Malfunction
    Date Received
    January 23, 2026
    Date of Event
    January 5, 2026
    Report Date
    January 7, 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

    ADDITIONAL INFORMATION: SECTION H MANUFACTURER NARRATIVE, SECTION B DESCRIBE EVENT OR PROBLEM, SECTION D DEVICE AVAILABLE FOR EVAL AND RETURNED TO MANUFACTURER. PART ANALYSIS: THE REPORTED CONDITION OF BPFMSUP1_ MAIN HAS A WHOLE DRAW FAILURE 4.1 THAT HAS POCKET FAILURE WAS CONFIRMED BY FSE AND SUBSEQUENTLY CONFIRMED IN THE DCHU INSPECTION PROCESS. ACCORDING TO WORK ORDER (B)(4), THE FIELD SERVICE ENGINEER (FSE) REPORTED THAT THE HALF HEIGHT DRAWER 4.1 NOT APPEARING ON THE BUS. THE FSE FOUND A DAMAGED RETRACTOR BAND. REPLACED THE RETRACTOR BAND; HOWEVER, THE UNIT WAS IDENTIFIED AS HAVING A FAULTY MOTHERBOARD (MOAB), INSTALLED THE REPLACEMENT DRAWER PROVIDED BY THE CUSTOMER AND SUCCESSFULLY TESTED ITS FUNCTIONALITY WITH THE CUSTOMER. DURING DCHU VISUAL INSPECTION: PN 122275-01: THE FIRST UNIT WAS RECEIVED BROKEN AT THE MIDSECTION, WITH NO EVIDENCE OF FLUID INGRESS OR ANY ADDITIONAL ANOMALIES OBSERVED. THE SECOND UNIT WAS RECEIVED WITH A CUT ON THE RIBBON CABLE, SHOWING EXPOSED COPPER STRANDS THAT EXHIBITED THERMAL DAMAGE. NO FLUID INGRESS OR OTHER ANOMALIES WERE OBSERVED. DURING DCHU TESTING: PN 122275-01: NO FURTHER TESTING WAS PERFORMED DUE TO SEVERE PHYSICAL DAMAGE OBSERVED ON THE FIRST UNIT, AND THERMAL DAMAGE IDENTIFIED ON THE CUT RIBBON CABLE, WITH EXPOSED COPPER STRANDS OF THE SECOND UNIT. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D). ROOT CAUSE: THE ROOT CAUSE OF THE COMPLAINT BPFMSUP1_ MAIN HAS A WHOLE DRAW FAILURE 4.1 THAT HAS POCKET FAILURE WAS DUE TO PHYSICAL AND THERMAL DAMAGED TO THE ASSY HARNESS RETRACTOR BAND CUBIE (PN 122275-01) WHICH EXPOSED THE COPPER STRANDS COMPROMISING THE DRAWER¿S FUNCTIONALITY.

    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, 16-APR-2013 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 HALF HEIGHT DRAWER 4.1 NOT APPEARING ON THE BUS. A FIELD SERVICE ENGINEER FOUND A DAMAGED RETRACTOR BAND. REPLACED THE RETRACTOR BAND; HOWEVER, THE UNIT WAS IDENTIFIED AS HAVING A FAULTY MOTHERBOARD (MOAB), INSTALLED THE REPLACEMENT DRAWER PROVIDED BY THE CUSTOMER AND SUCCESSFULLY TESTED ITS FUNCTIONALITY WITH THE CUSTOMER. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER REPAIRED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES THERE WAS A WHOLE DRAWER FAILURE 4.1 ASSOCIATED WITH A POCKET FAILURE. THE CUSTOMER ATTEMPTED MULTIPLE STATION REBOOTS; HOWEVER, THESE EFFORTS WERE UNSUCCESSFUL. THE CUSTOMER REPORTED THAT THERE WAS A DELAY IN PATIENT CARE. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THE FAILURE WAS CAUSED BY PHYSICAL AND THERMAL DAMAGE TO THE RETRACTOR BAND, EXPOSING COPPER STRANDS AND COMPROMISING DRAWER FUNCTIONALITY. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES THERE WAS A WHOLE DRAWER FAILURE 4.1 ASSOCIATED WITH A POCKET FAILURE. THE CUSTOMER ATTEMPTED MULTIPLE STATION REBOOTS; HOWEVER, THESE EFFORTS WERE UNSUCCESSFUL. THE CUSTOMER REPORTED THAT THERE WAS A DELAY IN PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221858 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown