FDA Adverse Event
Malfunction
Summary report: N
BD PYXIS¿ MEDBANK
MDR report key: 22020274
·
Received May 14, 2025
Report
- Report Number
- 2016493-2025-80165
- Event Type
- Malfunction
- Date Received
- May 14, 2025
- Date of Event
- April 17, 2025
- Report Date
- May 13, 2025
- Manufacturer
- CAREFUSION 303, INC.
- Product Code
- BRY
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT UNABLE TO LOGIN. A TECHNICAL SUPPORT SPECIALIST CHECKED THE MEDBANK MY Q-LINK AND FOUND THE USERNAME WAS ACTIVE. THE TSS PROVIDED THE USERNAME AND GENERIC PASSWORD, CUSTOMER CONFIRMED THAT THE USER THEN ABLE TO LOGIN WITHOUT ANY ISSUES. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE DEVICE.
Description of Event or Problem · 0
IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE BD PYXIS¿ MEDBANK, UNABLE TO LOGIN. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHEN THE USER TRIED TO DISPENSE THE MEDICATIONS TO THE PATIENT. HOWEVER, THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED DUE TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1217679 | BD PYXIS¿ MEDBANK | AUTOMATED DISPENSING CABINET | BRY | CAREFUSION 303, INC. | 169-11 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |