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

Model Number 4540008-07

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Diarrhea (1811)

Event Date 12/17/2023

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.Status: task completed.Sample/s evaluation: final control flow rate report of affected batch 23e27ged41 was reviewed.For final control flow rate report, the average flow rate deviation from the nominal flow rate was between 5.31% and 10.81%.As no complaint sample was received, further investigation is not possible.There are some possibilities that can cause the sample empties faster than nominal time in actual application, such as one or combination factors of more than one as below: factor 1 temperature based on customer description, the filter is not attached to the skin by the nurse.Referring to ifu, the flow restrictor is calibrated to work at 31°c.To maintain a stable flow rate, the flow restrictor should be in close contact with the patient's skin at all times (31°c).Figure 1: ifu statement.Factor 2 folded outer shell (outer layer) folded outer shell (outer layer) will also act as the external pressure to elastomeric membrane and increase the flow rate of the product.Figure 2: ifu statement.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.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: "pump-fast flow".According to the customer: "circumstances in which it occurred:treatment antibiotic tazocillin 12 grams prepared by an i.D.E.In a volume of 250 milliliters.The filter is not attached to the skin by the nurse.Patient apyretic with an ambient temperature of at least 23 celsius (°c) in the living room.Patient says he puts his diffuser on his bedside table.Treatment takes 15 hours to 20 hours instead of 24 hours.".

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 23e27ged41, there is no abnormality and no such defect detected at in process and at final control inspection.Sample/s evaluation: final control flow rate report of affected batch 23e27ged41 was reviewed.For final control flow rate report, the average flow rate deviation from the nominal flow rate was between 5.31% and 10.81%.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.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: 18675151
• MDR Text Key: 334983996
• Report Number: 9610825-2024-00076
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4540008-07
• Device Lot Number: 23E27GED41
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/27/2023
• 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
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 95 KG