inforMED
MalfunctionMEB

EASYPUMP

Received Jun 22, 2026

Report 9610825-2026-00323 · MDR key 25585296

Device

Generic name

Pump, Infusion, Elastomeric

Catalog number

4540008-07

Lot number

UNKNOWN

Product problems

  • Excess Flow or Over-Infusion

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

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 SUBMISSION # K081905.

Description of Event or Problem

AS REPORTED BY THE USER FACILITY: THIS PUMP WAS DOCUMENTED TO FINISH 8 HOURS EARLIER THEN IT SHOULD HAVE AS PER OUR RECORDS OF START AND FINISH TIME. NO PATIENT INJURY REPORTED.