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

Catalog Number	4540016-07
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	10/30/2024
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 event description: first installation on a patient, diffuser connected at 3pm on (b)(6) 2024, was empty this morning.Every precaution was taken to avoid this situation.The patient is experiencing undesirable effects that will be detrimental to the continuation of his treatment.
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.Additional information: b3 date of event d9 device returned to manufacturer device history record (dhr): reviewed the dhr for batch 24c04ged81, there was no defect encountered during in process and at final control inspection.Sample evaluation: received one 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, no solution was observed in the sample and the sample was not 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.Some white precipitation was observed at the patient connector of the sample.Investigation results: final control 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 1.72% and 5.70%.No abnormality was observed from final control flow rate report as all samples were within specifications of ±15%.The received sample was weighed at 60.36g.The average weight of an unfilled easypump ii for this article is 60g and the retained volume should be [?]3ml.Therefore, the pump is emptied upon receiving.White crystallization residues was observed throughout the flow restrictor of the received sample.The clamp clip of received sample was released and left overnight.No flow was observed.Blockage found at the flow restrictor area was due to white crystallize residues observed.Therefore, further investigation to determine the flow rate was not possible as the crystallization is not able to flush out from the flow restrictor.Fast flow rate as per customer description could not be identified.Nevertheless, 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 1.64 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: fast flow rate as per customer description could not be determined due to blockage, therefore we consider this complaint as not confirmed.The blockage of the sample was due to white crystalize residues present in the flow restrictor area.

• Brand Name: EASYPUMP 2
• Common Device Name: UMP, 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: 20789689
• Report Number: 9610825-2024-00851
• Device Sequence Number: 12715193
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Male