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

Model Number 4540016-07

Device Problem Improper Flow or Infusion (2954)

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

Event Type  malfunction  

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.

Event Description

As reported by the user facility information by bbm sales organization in france: "pump fast flow" according to the customer: fast flow.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).Root cause analysis: sample/s evaluation: the dhr of batch 22l01ged8r was reviewed.The affected batch was hold back at final control due to leaking at big bottom cap prior flowrate test.The batch was then reworked under sop elastomeric infusion system - correction procedure (hc-my01-m-5-4-16-021-0), 6.6.6.Rework method: opening pressure test.Under this rework method, new flow restrictor including new filter was replaced to the pump.After rework process, the batch was tested as per in-process (doc.No.: hc-my01-m-5-4-10-407-0) and final control (doc.No.: hc-my01-5-4-10-601-0) specification.The batch was released passed all test, which including flow rate test.The flow rate report of affected batch 22l01ged8r was reviewed.For final control flow rate (after eto) report, the average flow rate deviation from the nominal flow rate was between -5.05% and 0.57%.Received 1 used and filled easypump ii lt 100-50-s-eu/sa.As received condition, the clamp clip of received sample was clamped, and red closing cone was connected to the patient connector.Visual inspection had done throughout the received sample.No abnormality was observed.The sample was decontaminated and sent for flow rate test (20240117860).The flow rate deviation from nominal flow rate for received sample was -6.07%.The flow rate of received sample was within the specification ±15% deviation from nominal flow rate.Summary of root cause analysis: since the flow rate of received sample was within the specification, hence we considered this complaint as not confirmed.Cause : cause could not be determine the flow rate of received sample was within the specification after sent for flow rate test, which is according to test method 116008 under lab condition.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 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, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18270723
• MDR Text Key: 329806893
• Report Number: 9610825-2023-00555
• 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: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4540016-07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• 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