FDA Adverse Event
Malfunction
Summary report: N
EASYPUMP
MDR report key: 25233325
·
Received May 20, 2026
Report
- Report Number
- 9610825-0260-00237
- Event Type
- Malfunction
- Date Received
- May 20, 2026
- Report Date
- May 20, 2026
- Manufacturer
- B BRAUN MELSUNGEN AG
- Product Code
- MEB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
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 SUBMISSION # K081905.
Description of Event or Problem · 0
ACCORDING TO THE EVENT DESCRIPTION: TWO COMMUNITY NURSES REPORTED AN EXCESSIVELY RAPID FLOW RATE: INFUSION PUMPS FILLED TO 120 ML FOR A PLANNED 12-HOUR ADMINISTRATION WERE EMPTY AFTER 9 TO 10 HOURS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 512998 | EASYPUMP | PUMP, INFUSION, ELASTOMERIC | MEB | B BRAUN MELSUNGEN AG | 25L17GED41 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |