FDA Adverse Event Malfunction Summary report: N

BD PYXIS¿ MEDBANK TOWER

MDR report key: 23541434 · Received November 13, 2025

Report

Report Number
2016493-2025-134720
Event Type
Malfunction
Date Received
November 13, 2025
Date of Event
February 15, 2024
Report Date
November 7, 2025
Manufacturer
CAREFUSION 303, INC.
Product Code
BRY
PMA / PMN Number
EXEMPT
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
IL, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Additional Manufacturer Narrative · 0

THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING JANUARY 2022-DECEMBER 5, 2024, UNDER CAPA 10308384. THE LATE SUBMISSION OF THIS REPORT IS JUSTIFIED BY THE THOROUGH AND DETAILED NATURE OF THE RETROSPECTIVE REVIEW PROCESS. THIS PROCESS WAS ESSENTIAL TO ACCURATELY CAPTURE ALL RELEVANT DATA AND ENSURE THE INTEGRITY OF OUR REPORTING. WE HAVE INCLUDED THE CAPA REFERENCE FOR THE RETROSPECTIVE REVIEW IN THE ADDITIONAL MANUFACTURER NARRATIVE SECTION OF THE FDA FORM 3500A, AS RECOMMENDED. SERIAL NUMBER IS NOT REPORTED IN COMPLAINT. PER SWI, (B)(4) COMPLAINT INVESTIGATION, IF SERIAL NUMBER NOT AVAILABLE, THEN COMPLAINT HISTORY REVIEW (CHR) IS NOT REQUIRED. NO VALID SERIAL NUMBER ATTACHED TO COMPLAINT RECORD. PER SWI (B)(4) COMPLAINT INVESTIGATION, IF NO SERIAL NUMBER IS PROVIDED, A DEVICE HISTORY REVIEW IS NOT REQUIRED. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE MEDICATION WAS NOT SHOWING ON THE PATIENT'S PROFILE. A TECHNICAL SUPPORT SPECIALIST ADVISED THE CUSTOMER TO CONTACT THE PHARMACY TO SEE IF THEY WOULD ADD THIS MEDICATION TO THE PATIENT'S PROFILE OR GRANT THE DON PHARMACY ADMINISTRATOR ACCESS SO THIS MEDICATION COULD BE DESIGNED AND REASSIGNED. THE SYSTEM FUNCTIONED AS INTENDED AFTER BEING ASSESSED BY THE TECHNICAL SUPPORT SPECIALIST.

Description of Event or Problem · 0

IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS¿ MEDBANK TOWER SYSTEM MEDICATION WAS NOT SHOWING ON THE PATIENT'S PROFILE WHEN TRYING TO ISSUE MEDICATION DOXYCYCLINE HYC CAP 100 MG TO PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1984228 BD PYXIS¿ MEDBANK TOWER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 169-11

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown