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

Model Number	4540008-07
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Diarrhea (1811)
Type of Reportable Event	Malfunction
Event or Problem Description
According to the event description: an infuser ran over 14 hours instead of 24 hours.Patient had loose stools, which could potentially be due to the drug being administered too fast, or could be a side effect from other medication they are taking.
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 24g21ged42, 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 24g21ged42 was reviewed.For final control flow rate report, the average flow rate deviation from the nominal flow rate was between (b)(4).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 flow restrictor is calibrated at 31°c due it is approximately the temperature that arms will be.The flow restrictor might vary according to the fixing body position (and temperature of that body part).These products can be used for different therapies so it#s impossible to calibrate it for two or three different temperatures at the same time.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 10 ml/hr to 11.8 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.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: 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: 21631479
• Report Number: 9610825-2025-00129
• Device Sequence Number: 9511453
• Product Code: MEB
• UDI-Device Identifier: 04046964448485
• UDI-Public: (01)04046964448485(11)240721(17)290701(10)24G21GED42
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 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 Model Number: 4540008-07
• Device Lot Number: 24G21GED42
• 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: 02/17/2025
• Initial Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2024
• 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