MAUDE Adverse Event Report: B BRAUN MELSUNGEN AG EASYPUMP 2; ELASTOMERIC PUMPS

Model Number	4540016-07
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).A follow-up report will be provided after the examination results are 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.
Event or Problem Description
According to the customer facility: "the pump leaked on the patient and was returned.There is probably a leak in the pump or the associated hose.The drops were clearly visible at the connection point between the pump and the tube.".
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number: (b)(4).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.Received one sample of easypump ii lt 100-50-s-eu/sa without original packaging.Visual inspection was carried out.As received condition, the clamp clip was closed, and patient connector is not connected to wing cap.Batch number sticker attached on the big bottom cap was 24g10ged81.Pump was filled with 5fu.Preliminary investigation observed no crack at the filter but white crystallization was observed around the filter welded area.When sample was unclamped, solution immediately flow out of the filter.Red dye was allowed to pass through the filter for better observation.Filter is a purchased component from supplier.Affected filter batch: 255896, material short text batch: 15322395 filter easypump iv and pain 255896.Summary of root cause analysis: filter leak was observed from the returned complaint sample.Hence, this complaint is considered as confirmed.Filter is a purchased component, and thus supplier is notified for further investigation and necessary action.Cause: failure from supplier.Corrections/containment plans with effective date: not applicable.Corrective actions with effective date: a notification was issued to supplier (200365290 for affected filter batch).An approved project was initiated to address filter leakage issue.

• Brand Name: EASYPUMP 2
• Common Device Name: ELASTOMERIC PUMPS
• Manufacturer (Section D): B BRAUN MELSUNGEN AG; carl-braun str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B BRAUN MELSUNGEN AG; carl-braun str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 21595077
• Report Number: 9610825-2025-00084
• Device Sequence Number: 8925341
• Product Code: MEB
• UDI-Device Identifier: 04046964448607
• UDI-Public: (01)04046964448607(11)240710(17)290701(10)24G10GED81
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2025

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 Model Number: 4540016-07
• Device Lot Number: 24G10GED81
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2024
• 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 Sex: Unknown