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

Model Number 4540016-07

Device Problems Fluid/Blood Leak (1250); Insufficient Flow or Under Infusion (2182)

Patient Problem Discomfort (2330)

Event Type  malfunction  

Event Description

As reported by the user facility information by bbm sales organization in france: "chemo leakage".According to the complainant a leak from the pump in the patient was noted.The patient did not take the full prescribed dose.In addition, there is a cutaneous risk due to chemotherapy spilling onto the skin.

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.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).Root cause analysis: device history record (dhr):- reviewed the dhr for batch 22l01ged8r, which was a reworked batch for 22l01ged81 with holdback at final control inspection on failed tightness test (leaked between step down tube and triangle tube at big bottom cap).Rework was performed on the batch according to sop hc-my01-m-5-4-16-021-0.After reworked, no such defect was detected at in process and at final control inspection, therefore, this batch was released.Sample/s evaluation: as there is no sample received, further investigation is not possible.The investigation is only done based on the complaint description and photo provided that indicated the leakage point.The pump was empty and the batch number on the bbc was 22l01ged8r.According to historical data, leakage below the bbc was due to leakage at triangle tube-step down tube connection.Analysis: this complaint batch was a rework batch 22l01ged8r with holdback at final control inspection on failed tightness test due to leak at bottom bbc.The holdback batch was reworked according to sop hc-my01-m-5-4-16-021.After the batch was reworked, it was tested according to specification (hc-my01-m-5-4-10-601-0) and released after the products are tested to be within specification.The rework does not cause any adverse impact to the product.An approved project is in place to further address issues with triangle tube-step down tube connection leakage.However, during the rework, the root cause was under investigation.Upon the root causes were identified, mitigation actions have been implemented to address the issue.The major contributors to the defect have been immediately rectified after the root causes were identified.Summary of root cause analysis : as no sample was received for investigation, and leakage was not able to observed from the received picture, this complaint is not confirmed.However, an approved project is in place to further address issues with triangle tube-step down tube connection leakage.Cause : cause could not be determine no leakage was observed from the picture provided.Corrections/containment plans with effective date: not applicable corrective actions with effective date: not applicable justification: not confirmed 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.

• 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: 18681882
• MDR Text Key: 335205440
• Report Number: 9610825-2024-00078
• 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,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• 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: 22L01GED8R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2022
• 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