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

Model Number 4540040-07

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Discomfort (2330)

Event Date 08/25/2023

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: "product-overflow" according to the customer "100ml diffuser in 30 minutes, only flowed for 15 minutes (flow rate x2).The patient felt slight discomfort at the end of the infusion, without loss of consciousness.Protocol (volume, filling, diluent) tazocillin 4gr diluted in 100ml of 0.9% nacl.".

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report # (b)(6) as no sample and no meaningful picture was provided, proper investigation on malfunction could not be performed.Hence, the complaint is considered as not confirmed.Device history record (dhr): reviewed the dhr for batch 22m04gee42, there is no such defect detected at in process and at final control inspection pertaining flow rate issue.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 PUM,
• 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: 17913836
• MDR Text Key: 325853912
• Report Number: 9610825-2023-00460
• 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: 11/14/2023

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: 4540040-07
• Device Lot Number: 22M04GEE42
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 10/11/2023
• Supplement Dates Manufacturer Received: 09/13/2023
• Supplement Dates FDA Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2022
• 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
• Patient Age: 79 YR
• Patient Sex: Female