FDA Adverse Event Malfunction Summary report: N

EASYPUMP

MDR report key: 23583538 · Received November 18, 2025

Report

Report Number: 9610825-2025-00673
Event Type: Malfunction
Date Received: November 18, 2025
Date of Event: October 7, 2025
Report Date: November 18, 2025
Manufacturer: B BRAUN MELSUNGEN AG
Product Code: MEB
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW- UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE. NOTE: THIS REPORTED IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC. 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 INFORMATION: UDI NUMBER (B)(4). PREMARKET SUBMISSION # K081905.

Description of Event or Problem · 0

ACCORDING TO THE EVENT DESCRIPTION: "THE PROBLEM AT CAC ELOUED: THE ISSUE CONCERNS ACCELERATED INFUSION RATES IN 6 PATIENTS (ONLY THOSE WHO REPORTED IT: THE OTHERS MAY BE UNAWARE). THE INFUSION RATE WAS ACCELERATED FROM 48 HOURS TO ONLY 10-15 HOURS, LEADING TO SIDE EFFECTS DUE TO TOXICITY, MAINLY NAUSEA. THE PRODUCT ADMINISTERED IN THE EASY PUMPS WAS 5-FLUOROURACIL".

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2362853	EASYPUMP	PUMP, INFUSION, ELASTOMERIC	MEB	B BRAUN MELSUNGEN AG		23F20GED91

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown