MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG EASYPUMP; PUMP, INFUSION, ELASTOMERIC

Catalog Number	4540008-02
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complainant, the easypump was infusing too quickly.Reportedly, the pump was filled with fluorouracil (5fu) using normal saline (ns) as the diluent.The nominal fill was 240 milliliters (ml).Although the pump should have infused over 24 hours, the chemotherapy was completed in 8 hours.The reported stated that the "patient has been educated on the factors that can influence flow rate (such as temperature and position of the pump, etc.) and has used easypump now for about 6 months." no patient complications were reported as a result of this event.
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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).A review of the device history record (dhr) was performed for the reported lot number and no abnormalities or nonconformances were noted during the in process or final product inspection.Final control flow rate report of affected batch 24f02ge511 was reviewed.For final control flow rate report, the average flow rate deviation from the nominal flow rate was between -3.54% and 2.11%.No sample was provided for evaluation.Based on the data from the investigation we are unable to determine the root cause of the reported incident.The reported defect was unable to be confirmed.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: EASYPUMP
• Common Device Name: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 21267444
• Report Number: 9610825-2025-00018
• Device Sequence Number: 3664761
• Product Code: MEB
• UDI-Device Identifier: 04046964448485
• UDI-Public: (01)04046964448485(10)24F02GE511
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K081905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 4540008-02
• Device Lot Number: 24F02GE511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Male