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

Catalog Number	4540016-02
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The complainant reported that the easypump did not infuse while connected to the patient.After disconnection, the device was returned to the pharmacy, where it was found to have leaked chemotherapy under the hood.The facility indicated that the end of the line had a closed system, specifically, a chemoclave¿.Additional information revealed that the patient was familiar with the system, as this was their seventh treatment cycle.When the patient returned, the pump was full, all clamps were open, and the tubing had been taped to the patient as per standard practice.Reportedly, the device had been left under the chemo hood with the closed system cap in place.The patient did not receive the prescribed dose of flurouracil (5-fu).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).One (1) sample was submitted to the manufacturer for evaluation.Through visual examination, some white precipitation was observed at the filter and connector.The sample was placed on white paper and unclamped for better visualization of liquid flow.After ten minutes, no solution flow was observed.After removing the spiros closed male connector, the solution was able to flow out from the patient connector immediately without any abnormality.Based on the complaint description, the pump was connected to the patient.It is assumed that the sample was primed before use and not initially blocked.Blockage was only detected during application.Furthermore, after removing the spiros closed male connector, which is not part of easypump ii, solution can flow without any abnormality from the sample.Thus, it is unlikely that the blockage observed was due to manufacturing error.A review of the device history record (dhr) performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.Based on the investigation, no blockage was observed from the returned complaint sample.The complaint is considered not 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: 22174856
• Report Number: 9610825-2025-00357
• Device Sequence Number: 7818060
• Product Code: MEB
• UDI-Device Identifier: 04046964448607
• UDI-Public: (01)04046964448607(11)240807(17)290801(10)24H07GE551
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/25/2025

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: 4540016-02
• Device Lot Number: 24H07GE551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Male