EASYPUMP
Received Jul 1, 2026
Report 9610825-2026-00320 · MDR key 25677449
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
B. Braun Melsungen AgCatalog number
4540018-02
Lot number
25B01GE561
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 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.
Description of Event or Problem
AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: WE ARE CURRENTLY USING EASYPUMP ELASTOMERIC INFUSION PUMP II LT 270-54-S. (PRODUCT NUMBER 4540018-02; LOT NUMBER 25B01GE561) TO ADMINISTER FLUOROURACIL INFUSIONS FOR AN ONCOLOGY PATIENT. THE PATIENT HAS REPORTED THAT HIS FLUOROURACIL INFUSIONS HAVE COMPLETED SIGNIFICANTLY EARLIER THAN EXPECTED ON MULTIPLE OCCASIONS, WITH THE BULB EMPTYING APPROXIMATELY 12-17 HOURS AHEAD OF THE SCHEDULED COMPLETION TIME. I SPOKE DIRECTLY WITH THE PATIENT REGARDING POTENTIAL FACTORS THAT COULD AFFECT THE INFUSION RATE. HE REPORTS THAT HE DOES NOT EXPOSE THE DEVICE TO EXTREME TEMPERATURES, DOES NOT LIE ON OR COMPRESS THE BULB, AND GENERALLY HANDLES THE DEVICE WITH GREAT CARE. BASED ON OUR DISCUSSION, THERE DO NOT APPEAR TO BE ANY OBVIOUS ISSUES RELATED TO DEVICE HANDLING OR STORAGE.