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

Model Number 4540016-07

Device Problems Fluid/Blood Leak (1250); Excess Flow or Over-Infusion (1311)

Patient Problem Discomfort (2330)

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.Root cause analysis: sample/s evaluation: as there are no sample received, further investigation is not possible.The investigation was only done based on picture provided, complaint description, and batch manufacturing record review.From the picture provided, the leakage was not able to be identified.According to complaint description and the indication in the figure, the leak observed are between the bag and the tubing, which likely to be referring to the leakage at below bbc (big bottom cap).Reviewing historical data, leakage below the bbc is due to leakage at triangle tube and step down tube connection.An approved project has been approved for issues the triangle tube and step down tube connection leakage issue.Summary of root cause analysis: as neither complaint sample nor meaningful picture was received, further investigation to identify the defect as per customer described is not possible.Therefore, the complaint is considered as not confirmed.Cause : cause could not be determine.Neither sample nor meaningful picture is available for investigation.Corrections/containment plans with effective date: not applicable.Corrective actions with effective date: not applicable.Justification: not confirmed.

Event Description

As reported by the user facility information by bbm sales organization in france: "chemo leakage" according to the customer: "leaks from the 5fu of the pumps in 2 patients were noted by the private nurses.The leaks observed are between the bag and the tubing (and not at the level of the implantable chamber).The diffuser leaks in the bag either the same day of connection or 24 hours later.Patients did not receive the full prescribed dose.In addition, chemotherapy leaks into patients' homes.Recurring leaks since the start of the market.".

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.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 are no sample received, further investigation is not possible.The investigation was only done based on picture provided, complaint description, and batch manufacturing record review.From the picture provided, the leakage was not able to be identified.According to complaint description and the indication in the figure, the leak observed are between the bag and the tubing, which likely to be referring to the leakage at below bbc (big bottom cap).Reviewing historical data, leakage below the bbc is due to leakage at triangle tube and step down tube connection.An approved project is in place to further address issues with triangle tube and step down tube connection leakage.Analysis the complaint batch 22l01ged8r was a reworked batch with holdback at final control inspection on failed tightness test due to leaked between step down tube and triangle tube connection.Rework was performed according to sop hc-my01-m-5-4-16-021 where the old step down tube and tubing were removed and replaced with new step down tube, triangle tube and microbore tube.Assembly of the rework complaint batch was done according to sop elastomeric infusion - final assembly (hc-my01-m-5-4-16-015, version 34.0) and sop elastomeric infusion system - correction procedure after the batch was reworked, it was tested according to specification (hc-my01-m-5-4-10-601-0) and release after the product are tested to be within specification.The rework process will not have adverse effect to the pump.However, during the rework, the root cause of the complaint defect was still under investigation.Upon the root cause were identified, mitigation actions have been implemented to address the issue.The major contributors of the defect have been immediately rectified after the root causes were identified.Summary of root cause analysis: as neither complaint sample nor meaningful picture was received, further investigation to identify the defect as per customer described is not possible.Therefore, the complaint is considered as not confirmed.However, potential root cause has been identified and an approved project is in place to further address issues with triangle tube and step down tube connection leakage.Cause : cause could not be determine neither sample nor meaningful picture is available for investigation.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 INFUSION SYSTEMS
• 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: 18661353
• MDR Text Key: 334795148
• Report Number: 9610825-2024-00068
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 4540016-07
• Device Lot Number: 22L01GED8R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2024
• 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