MAUDE Adverse Event Report: B BRAUN MEDICAL INC EASYPUMP 2; ELASTOMERIC PUMPS

Model Number 4540008-07

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Discomfort (2330)

Event Date 02/02/2024

Event Type  malfunction  

Event Description

As reported by the user facility information by bbm sales organization in france: "pump-fast flow" according to the customer: "friday february 02 2024 two nursing offices called us to inform us that the 270ml/27h diffusers, used for 120ml/12h, were used in 3 hours.".

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 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: final control flow rate report of affected batch 23h02ged42 was reviewed.For final control flow rate report, the average flow rate deviation from the nominal flow rate was between -1.87% and 4.76%.Device history record (dhr):- reviewed the dhr for batch 23h02ged42, there is no abnormality and no such defect detected at in process and at final control inspection.As no complaint sample was received, further investigation is not possible.Summary of root cause analysis: as no complaint sample was received, further investigation is not possible.Therefore, this complaint is considered as not confirmed.Cause : cause could not be determine.As no complaint sample was received, further investigation is not possible.

• Brand Name: EASYPUMP 2
• Type of Device: ELASTOMERIC PUMPS
• Manufacturer (Section D): B BRAUN MEDICAL INC; 901 marcon blvd.; allentown PA 18109
• Manufacturer (Section G): B BRAUN MEDICAL INC; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18842037
• MDR Text Key: 337258463
• Report Number: 9610825-2024-00150
• 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: 03/05/2024

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: 4540008-07
• Device Lot Number: 23H02GED42
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/02/2023
• 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