EASYPUMP 2
Received Jun 11, 2026
Report 9610825-2026-00303 · MDR key 25471220
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
B.braun Melsungen AgCatalog number
4540016-07
Lot number
25H13GED81
Product problems
- Fluid/Blood Leak
Patient
NA · Unknown
- Skin Inflammation/ Irritation
Narrative
Description of Event or Problem
AS REPORTED BY THE USER FACILITY: THE PUMP WAS DEFECTIVE. THE FILTER APPEARS TO BE BROKEN. PATIENT RECEIVED ONLY BARELY ONE-THIRD OF THE THERAPY, AND THE TREATING ONCOLOGIST HAS NOW DISCONTINUED THE TREATMENT; THE PATIENT WILL NOT RECEIVE THE REMAINING FLUOROURACIL. THE PATIENT PRESENTED WITH A SMALL WHITE CRYSTALLIZATION ON THE SKIN.
Additional Manufacturer Narrative
THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE. PLEASE NOTE, THIS DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. IT IS BEING REPORTED DUE TO A SIMILAR DEVICE BEING MARKETED WITHIN THE US WITH THE FOLLOWING INFO: UDI NUMBER: (B)(4). PREMARKET SUBMISSIOSN # K081905.