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

Catalog Number	4540016-07
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility, translation of user facility information by bbm sales organization in france: wear and tear on the balloon caused the chemotherapy to diffuse.The chemotherapy therefore leaked onto the patient at home.The outer balloon was torn in 2 places.The label has also given way on contact with the chemotherapy.
Additional Manufacturer Narrative
This report has been identified as b.Braun melsungen ag internal report: (b)(4).The complaint is under evaluation.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.
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.Root cause analysis: no sample was provided for investigation.In addition, the complaint defect is also not able to be identified from the provided picture.The investigation is only done based on batch manufacturing review, complaint description, and historical data.The batch number was 23e12ged81, dhr was reviewed and there is no abnormality, and no similar defect was detected at in process and at final control inspection.According to the description, the outer balloon was torn at 2 places.Further inquiry (refer below attached email) was posted to the customer and the "torn" as described by the customer potentially refers to the punched hole at outer shell.The punch holes serve to release the built up pressure when the pump is filled up with solution to avoid cracking.It is not a defect though.As neither sample nor meaningful picture provided, we are not able to identify the root cause.Potential root causes have been identified and actions are implemented/planned to address the issue.Summary of root cause analysis: as neither complaint sample nor meaningful picture was received, further investigation to identify the defect as customer described is not possible.Therefore, the complaint is considered as not confirmed.

• Brand Name: EASYPUMP® II
• Common Device Name: ELASTOMERIC INFUSION PUMP
• 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, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18816770
• Report Number: 9610825-2024-00137
• Device Sequence Number: 8271547
• Product Code: MEB
• UDI-Device Identifier: 04046964448515
• UDI-Public: (01)04046964448515
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 06/03/2024

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: 4540016-07
• Device Lot Number: 23E12GED81
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 06/03/2024
• Date Device Manufactured: 05/12/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown