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

Catalog Number	4540016-07
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
According to the event description: the easypump ran through in 22 hours instead of 50 hours.No patient complications were reported as a result of this event.
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 23h28ged81, there was no defect encountered during in process and final control inspection.No sample and no picture received for further investigation.Investigation results: final control flow rate report of affected batch 23h28ged81 was reviewed.For final control flow rate report, the average flow rate deviation from the nominal flow rate was between -4.97% and 3.17%.As no complaint sample was received, further investigation was not possible.There are some possibilities that can cause the sample to empty 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.

• Brand Name: EASYPUMP 2
• 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: 21634982
• Report Number: 9610825-2025-00133
• Device Sequence Number: 9372148
• Product Code: MEB
• UDI-Device Identifier: 04046964448607
• UDI-Public: (01)04046964448607(11)230828(17)280801(10)23H28GED81
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2025

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 Catalogue Number: 4540016-07
• Device Lot Number: 23H28GED81
• 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: 02/21/2025
• Initial Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2023
• 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