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

Model Number	4540032-07
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
According to the customer facility: "patient has a 7-day pump with fluorouracil (5fu) and comes to change to a new 7-day pump on this day.The patient says that the pump was already empty after 3 days.This cannot really be verified.The patient said she felt a little nauseous, but otherwise did not notice much.She was also unable to say exactly when the pump was empty.This means that ultimately it remains unclear whether the pump was really empty after 3 days.We advised her to contact us immediately if this should happen again.According to the label, the pump had been filled correctly.Serious possible consequences: if the pump really was empty after 3 days, this could lead to increased side effects.".
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 23e04gee31, there was no defect encountered during in process and final control inspection.Sample evaluation: received one sample of easypump ii lt 270-135-s-eu/sa without original packaging.The batch number on the big bottom cap of the sample was 23e04gee31.Upon received, no solution was observed in the sample and the sample was clamped.A medication label attached on the tubing of the sample indicates that the sample was used to be filled with fluorouracil.Its filling port was closed with discofix cap, whereas its patient connector was closed with a white closing cone.Investigation results: the flow rate report of affected batch 23e04gee31 was reviewed.For final control flow rate report, the average flow rate deviation from the nominal flow rate was between 0.47% and 5.94%.The received sample was weighed and recorded at 79.32g.An unfilled easypump for this article typically weighs 75g, and the retained volume should be #3g.This indicates that the remaining solution at received sample was around 1g (almost emptied).By visual inspection, crack and white crystallized residue was found at the filling port and patient connector of received sample.Then, the sample was decontaminated and sent for flow rate test.The flow rate deviation from nominal flow rate for received sample was -15.15%.Fast flow rate as per customer description was not observed at received sample.The slow flow rate of the received sample during testing was potentially due to white crystallization observed at the received sample.The crystallization / precipitation of drug will affect the flow rate of the sample.The crystallization / precipitation will cause blockage on the path of the solution.There are some drugs (e.G.5fu, cefepime) which tend to crystallize / precipitate at some special conditions.The risk of crystallization is given by the drug itself and may affect some functions of the pump (filter, microbore, glass tube).However, there are some possiblities that can cause fast flow rate to occur during application, such as one or combination factors listed 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 2ml/hr to 2.36ml/hr.Factor 2: external pressure external pressure such as squeezing or lying 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 the ifu.Factor 3: folded outer shell according to the ifu, the outer layer has to be unfolded properly prior filling.Folded outer shell will act as the external pressure to elastomeric membrane and increase the flow rate of the product.Conclusion: slow flow rate was observed on the received complaint sample.Slow flow rate of the received sample as potentially due to white crystallization observed on the received sample.Since fast flow rate as per customer description was not observed on the received sample, hence we considered this complaint 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: 21167801
• Report Number: 9610825-2024-01030
• Device Sequence Number: 4603777
• Product Code: MEB
• UDI-Device Identifier: 04046964448843
• UDI-Public: (01)04046964448843(11)230504(17)280501(10)23E04GEE31
• 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,Followup
• Report Date (Section B): 04/07/2025

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
• Device Model Number: 4540032-07
• Device Lot Number: 23E04GEE31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 04/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2023
• 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 Age: 70 YR
• Patient Sex: Female