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

Model Number 4540016-07

Device Problem Fluid/Blood Leak (1250)

Patient Problem Discomfort (2330)

Event Date 01/24/2024

Event Type  malfunction  

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.Sample/s evaluation: neither sample nor picture is available, hence further investigation to identify the defect as customer described is not possible.Dhr reviewed device history record (dhr):- reviewed the dhr for batch 23c18ged81, there is no abnormality and no such defect detected at in process and at final control inspection.Analysis: according to the customer descriptions, there was approximately 25 % of leakage from the filling port.Reviewing the historical date and the information provided, leakage is potentially due to valve leakage.However, further investigation to confirm the root cause is impossible as no complaint sample has been returned to bmi.An approved project is in place to further address issues with valve leakage.Summary of root cause analysis: as neither complaint sample nor picture was received, further investigation is not possible to identify the complained defect.Hence, the complaint is classified as not confirmed.However, based on the information provided by customer, potential root cause has been identified and actions are in place to address this issue.Cause : cause could not be determined neither sample nor picture is available, hence further investigation to identify the defect as customer described is not possible.Justification: not confirmed.

Event Description

According to the customer: when installing a 5fu pump, the nurse notices that the field in which the diffuser is located is wet.The 5fu appears to have spilled into the field.Empty broadcast 1/4.Leak at the tubing filling site.Probable non-return valve malfunction.

• Brand Name: EASYPUMP 2
• Type of Device: 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: 18882124
• MDR Text Key: 337860495
• Report Number: 9610825-2024-00168
• 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: 03/11/2024

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 Model Number: 4540016-07
• Device Lot Number: 23C18GED81
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/18/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1