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

Catalog Number 4540016-07

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/30/2024

Event Type  malfunction  

Event 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.

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.

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
• Type of Device: 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 ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18816770
• MDR Text Key: 336751359
• Report Number: 9610825-2024-00137
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 4540016-07
• Device Lot Number: 23E12GED81
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 03/01/2024
• Date Device Manufactured: 05/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1