FDA Adverse Event Malfunction Summary report: N

BD PYXIS¿ ES SERVER

MDR report key: 24741637 · Received March 31, 2026

Report

Report Number
2016493-2026-17925
Event Type
Malfunction
Date Received
March 31, 2026
Date of Event
March 4, 2026
Report Date
March 18, 2026
Manufacturer
CAREFUSION 303, INC.
Product Code
BRY
PMA / PMN Number
EXEMPT
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
TX, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Additional Manufacturer Narrative · 0

D4 & H4: SERIAL NUMBER, UNIQUE DEVICE IDENTIFIER AND MANUFACTURER DATE NOT AVAILABLE. D10: CONCOMITANT MED PROD DATA: ERJ, UTPOR1 , 4WB, ASC PACU, UTTDSUOR1, UTTDSUOR5, UTTEP3, UTTOR6, UTTEP3, UTTDSUOR1, ASC PACU, UTTDSUOR5, UTTEP2, GI LAB, UTTOR6, 4WB, 3WB, 2WA, 4WA, 6NOB, 6SO, 4WC, EDP, ER, IMC, ORP, PACUP, UPGILAB, UTPOR2, EDQ, SURGQ, UTQGILAB, UTQMS1, UTQMS2, UTQOR1, UTQOR1, CND, 02S, UTJDSU , UPGILAB, UTPGILAB, UTQOR1, UTQOR2, PACUP, UTPOR2 , CCER, IMC, ORP , AFTER HOURS, ICUJ , OBS, UTJDIALYSIS , UTJOBOR, 1CPP , 1CTH, 4NO , COVID1, MS1E, OB , MS1W , MS2E, 3F, EDH, OBH , 5NOA, WIIC, UTQMS1 , ERCA, UTQMS2 , UTTGILAB2, UTJPACU, UTJGILAB , UTJOR1, UTJORCORE, UTJOR2, UTJOR3. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE STATION DATABASE SYNCHRONIZATION FAILURE AS A PART OF DISASTER RECOVERY. A TECHNICAL SUPPORT SPECIALIST (TSS) WORKED WITH THE PRODUCT SUPPORT ENGINEER (PSE) TEAM AND IDENTIFIED THAT THE PRODUCTION SERVER DATABASE HAD BEEN RESTORED FROM A BACKUP, RESULTING IN THE LOSS OF APPROXIMATELY EIGHT MINUTES OF DATA. THE TSS THEN PERFORMED DISASTER RECOVERY REVERSE SYNCS ON STATIONS IN RETRY MODE AND EXECUTED FULL SYNCS ON ALL STATIONS TO ENSURE NO DATA MISMATCHES OCCURRED MOVING FORWARD. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOOTS THE DEVICE.

Description of Event or Problem · 0

IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ES SERVER, NDCPPYXAPP01 DISASTER RECOVERY. CUSTOMER REBOOTED DEVICE AND IT WAS STILL NOT COMMUNICATED WITH THE PYXIS WEBSITE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
799344 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC.

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown