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

Model Number	4540032
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
Additional 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.Device history record (dhr): reviewed the dhr for batch 21c25ge341, there was no defect encountered during in process and final control inspection.No sample and no picture was received for further investigation.Investigation results: final control flow rate report of affected batch 21c25ge341 was reviewed.For final control flow rate report, the average flow rate deviation from the nominal flow rate was between -1.29% and 3.76%.As no complaint sample was received, further investigation was 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.The temperature of the surrounding will affect the flow rate of the sample.For every increase of 1°c, the flow rate of the sample will increase approximately by 3%.For example, if the flow restrictor of the product reaches the temperature of 37°c, the flow rate of the sample will increase by approximately 18% which means the flow rate will increase from 2 ml/hr to 2.36 ml/hr.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.Factor 3: external pressure: external pressure such as squeezing or laying on the pump will increase the flow rate which cause the pump to empty earlier than the nominal time.Simulation of external pressure had been conducted.The flow rate of the product can increase when external force is applied to the pump.However, this external force is against the intended use of the product according to ifu.Conclusion: as no complaint sample was received, further investigation was not possible.Therefore, this complaint is considered as not confirmed.
Event or Problem Description
According to the customer: "the pump delivered 5fu in 72 hours instead of the scheduled 96 hours.For your information, the patient had a fever but treatment was interrupted during the fever episode.".

• Brand Name: EASYPUMP®
• Common Device Name: PUMP, INFUSION, ELASTOMERIC
• 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: 21409871
• Report Number: 9610825-2025-00045
• Device Sequence Number: 18477964
• Product Code: MEB
• UDI-Device Identifier: 04046964448843
• UDI-Public: (01)04046964448843(11)210325(17)260301(10)21C25GE341
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2026
• Device Model Number: 4540032
• Device Lot Number: 21C25GE341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown