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

Catalog Number	4540016-07
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	10/04/2024
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 24c04ged81, there was no defect encountered during in process and final control inspection.Sample evaluation: received 1 sample of easypump ii lt 100-50-s-eu/sa without original packaging.The batch number on the big bottom cap of the sample was 24c04ged81.Upon received, some clear solution was found remained in the sample and the sample was clamped.A medication label attached on the outer shell of the sample indicates that the sample was used to be filled with 5-fluorouracil.Its filling port was closed with discofix cap, whereas its patient connector was not closed with wing cap.Investigation results: the flow rate report of affected batch 24c04ged81 was reviewed.For final control flow rate report, the average flow rate deviation from the nominal flow rate was between (b)(4).The affected article is a glass-tube article.Visual inspection had done on the received sample.Glass tube was observed at patient connector.No abnormality was observed at received sample.The received sample was weighed and recorded at 66.83g an unfilled easypump for this article typically weighs 60g, and the retained volume should be [?]3g.This indicates that the remaining solution at received sample was around 3-5g.The sample was decontaminated and sent for flow rate test.The flow rate deviation from nominal flow rate for received sample was 3.85%.The flow rate of received sample was within the specification ±15% deviation from nominal flow rate.Referring to customers description, customer stated that her pump of 09/20/24 had gone to 31 hours or 26 hours instead of 48 hours.The pump with flow rate of 2ml/hr consists of glass tube that controlled the flow rate.Upon visual inspection, glass tube is observed, and the received sample passed the flow rate test as well.The fast flow phenomenon as per complaint was not detected during investigation.However, there are some possibilites that can cause fast flow rate to occur during application, such that one or combination factors are 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 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.Factor 3: folded outer shell according to 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: since the flow rate of received sample was within the specification, hence we considered this complaint as not confirmed.
Event or Problem Description
According to the event description: the patient had already stated that her pump of (b)(6) 2024 had gone to 31 hours instead of 48 hours.Reportedly the patient was given information on proper use of the infuser at home.She returns for her treatment on (b)(6) 2024 and her pump of october 4 went from 1:30 p.M.To 3:35 p.M., so in 26 hours.No patient complications were reported as a result of this event.

• 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: 20750456
• Report Number: 9610825-2024-00831
• Device Sequence Number: 8182318
• Product Code: MEB
• UDI-Device Identifier: 04046964448607
• UDI-Public: (01)04046964448607(11)240304(17)290301(10)24C04GED81
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 11/21/2024

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: 24C04GED81
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2024
• 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: Female