EASYPUMP
Received Jul 1, 2026
Report 9610825-2026-00341 · MDR key 25677044
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
B Braun Melsungen AgCatalog number
4540008-07
Lot number
25L14GED41
Product problems
- Insufficient Flow or Under Infusion
Patient
NA · Unknown
- Insufficient Information
Narrative
Description of Event or Problem
ACCORDING TO THE EVENT DESCRIPTION: "THE HOSPITAL AT HOME HAD AN INCIDENT WHERE A NUMBER OF EASYPUMPS HAD A RESIDUAL VOLUME OF APPROXIMATELY 90 ML EACH DAY, OVER A NUMBER OF DAYS (BATCH NUMBER 25N28GED41 EXP 12/01/30). THE MEDICATION THAT WAS USED WAS 18G TAZOCIN MIXED WITH SODIUM CHLORIDE." THE COMPLAINTANT WAS ENSURED THAT THE PUMP WAS KEPT AT WAIST HEIGHT, AT THE CORRECT TEMPERATURE AND THAT THE LINE WAS TAPED TO THE SKIN AT THE APPROPRIATE AREA.
Additional Manufacturer Narrative
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 INFORMATION: UDI NUMBER (B)(4). PREMARKET SUBMISSION # K081905.