FDA Adverse Event Malfunction Summary report: N

BD PYXIS¿ MEDFLEX 1000

MDR report key: 24725792 · Received March 30, 2026

Report

Report Number
2016493-2026-17251
Event Type
Malfunction
Date Received
March 30, 2026
Date of Event
December 31, 2025
Report Date
March 25, 2026
Manufacturer
CAREFUSION 303, INC.
Product Code
BRY
UDI-DI
10885403512704
PMA / PMN Number
EXEMPT
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
MD, 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, 13-MAR-2025 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 THE INCIDENT, IT WAS DETERMINED BY THE TECHNICAL SUPPORT SPECIALIST (TSS) WITNESSED THAT THE CUSTOMER ATTEMPTED TO ISSUE ROCEPHIN 1GM BUT QOH (QUANTITY ON HAND)SHOWED 0; ASSISTED IN VERIFYING THROUGH CYCLE COUNT THAT THE ITEM WITH QOH=4 WAS ACTUALLY FORTAZ/TAZICEF IN BIN 01 14 02, NOT ROCEPHIN IN BIN 01 13 01. DURING RESTOCK, CUSTOMER SCANNED THE ITEM ID INSTEAD OF THE LABEL BARCODE AND THEN INCORRECTLY COMPLETED A RESTOCK FOR BIN 01 14 02 USING ROCEPHIN. GUIDED THE CUSTOMER TO CORRECT THE COUNT BY CYCLE COUNTING THE BIN AND SETTING QOH=3. ADVISED NOTIFYING PHARMACY ABOUT THE INCORRECT MED OR BARCODE AND TO CHECK FOR YELLOW BANNER ERRORS AND CONTACT TSS IF THE APPLICATION DOES NOT PROCEED. CUSTOMER APPROVED CLOSING THE CASE.

Description of Event or Problem · 0

IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDFLEX 1000, THE CUSTOMER WAS UNABLE TO ISSUE, RESTOCK (4 UNITS), OR PERFORM A CYCLE COUNT FOR CEFTRIAXONE INJECTION 1 G. NO ACTION OCCURRED WHEN THE NEXT BUTTON WAS SELECTED. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION. HOWEVER, THERE WERE NO DELAYS OR ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
792086 BD PYXIS¿ MEDFLEX 1000 AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500004502000 10885403512704

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown