FDA Adverse Event Malfunction Summary report: N

EASYPUMP

MDR report key: 23036315 · Received September 12, 2025

Report

Report Number: 9610825-2025-00524
Event Type: Malfunction
Date Received: September 12, 2025
Date of Event: August 14, 2025
Report Date: September 12, 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 REPORT 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 INFO: UDI NUMBER (B)(4). PREMARKET SUBMISSION #K081905.

Description of Event or Problem · 0

ACCORDING TO THE EVENT DESCRIPTION: "02 EASYPUMP II PUMPS WERE ADMINISTERED TO 02 ADULT PATIENTS ON THE SAME DAY. THE 5- FLUOROURACIL SOLUTION WAS DELIVERED IN A PERIOD SHORTER THAN 46 HOURS SPECIFIED IN THE ORIGINAL PROTOCOL. THE PHARMACIST ESTIMATED THAT THE INFUSION LASTED LESS THAN ONE HOUR."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2330739	EASYPUMP	PUMP, INFUSION, ELASTOMERIC	MEB	B BRAUN MELSUNGEN AG		21G11GE381

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown