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

Model Number 4540016-07

Device Problem Fluid/Blood Leak (1250)

Patient Problem Chemical Exposure (2570)

Event Date 12/11/2023

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: " chemo leakage" according to the complainant the patient was being infused with fluorouracil for 48 hours.Reportedly at the end of the day the bag and sachet were damp and soaked.The 5fu leaked onto the nurse's arm and onto the ground.No patient complications were reported as a result of this event.

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 23d30ged51 with article 4540010-07, there is no such defect detected at in process and at final control inspection pertaining product leakage.Sample/s evaluation: received one sample of easypump ii lt 60-30-s-eu/sa in opened packaging.As received condition, the sample was unclamped, some water was filled, and the wing cap was attached.Analysis: discofix cap was removed, and no abnormality was observed.To analyze the root cause of leakage, the sample was filled with red dye solution until its nominal volume.The complaint sample was unclamped, and the solution flowed out immediately.No leakage was observed from filling port, valve area, silicone sleeve, filter and tube connection.However, reviewing the historical data, the complaint defect could be due to intermittent valve leakage.Potential root cause of intermittent valve leakage is due to improper position of silicon valve.Valve leakage is a known defect.An approved project is in place to further address issues with valve leakage.Summary of root cause analysis: no leakage nor abnormality was observed on complaint sample.Hence, we considered this complaint as not confirmed.Cause : cause could not be determine no leakage nor abnormality was observed on the complaint sample.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: 18528127
• MDR Text Key: 333053340
• Report Number: 9610825-2023-00697
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

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: 4540016-07
• Device Lot Number: 23C23GED81
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2023
• Initial Date FDA Received: 01/17/2024
• Supplement Dates Manufacturer Received: 12/22/2023
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2023
• 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