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

Catalog Number	4540008-07
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
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 complainant the pump does not have an infusion time of 27 hours as stated, but approximately 12 hours.The customer also said that the flow rate of 10 milliliters and hour (ml/h) did not work correctly for the patient.
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.Investigation results: device history record (dhr): reviewed the dhr for batch 23h29ged41, there was no defect encountered during in process and final control inspection.Sample evaluation: received 7 samples of easypump ii lt 270-27-s-eu/sa in original packaging packed in a carton box.The batch numbers on the printed primary packaging and the carton label were 23h29ged41.Investigation results: the flow rate report of affected batch 23h29ged41 was reviewed.For final control flow rate report, the average flow rate deviation from the nominal flow rate was between -12.42% to 0.70%.The 7 new and unopened easypump ii lt 270-27-s-eu/sa received in their original packaging indicated that the received samples are reference samples.The actual complaint sample was not received.When opened, no abnormalities were observed, the clamp clip of all samples were unclamped, and the patient connector was connected to its original wing cap.All samples were sent for flow rate test.The flow rate deviation from nominal flow rate for received sample was all within the specification ±15% deviation from nominal flow rate as in 12.80%, 5.74%, 5.93%, 8.21%, 5.94%, 6.77%, and 7.78%.However, there are some possibilities 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 10ml/hr to 11.8ml/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.Conclusion: since the flow rate of all samples received were within the specification, hence we considered this complaint 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: 20368473
• Report Number: 9610825-2024-00738
• Device Sequence Number: 17857470
• Product Code: MEB
• UDI-Device Identifier: 04046964448485
• UDI-Public: (01)04046964448485(11)230829(17)280801(10)23H29GED41
• 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): 10/19/2024

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: 4540008-07
• Device Lot Number: 23H29GED41
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 10/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown