MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG EASYPUMP® II; ELASTOMERIC INFUSION PUMP

Catalog Number	4540018-07
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun melsungen ag internal report (b)(4): the complaint is under evaluation.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
As reported by the user facility / translation of user facility information by bbm sales organization in switzerland: two patients were admitted to the department and therapy was started for the one on (b)(6) 2024 at 3 p.M., and for other around 4:35 p.M.Therapies ended on (b)(6) 2024 around 10 pm and the patients were quite red.The therapy ended up to 10 hours before the scheduled time.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Root cause analysis: device history record (dhr): reviewed the dhr for batch 23f02ged71, there is no abnormality and no such defect detected at in process and at final control inspection.Sample/s evaluation: the flow rate report of affected batch 23f02ged71 was reviewed.For final control flow rate (after eto) report, the average flow rate deviation from the nominal flow rate was between 4.38% and 8.75%.Received 1 easypump ii lt 400-40-s-eu/sa, which is a reference sample as bbm received it in original packaging.As received condition, the clamp clip of received sample was clamped, and wing cap was connected to the patient connector.Visual inspection had done throughout the received sample.No abnormalities was observed.The sample was decontaminated and sent for flow rate test (202403041658).The flow rate deviation from nominal flow rate for received sample was -0.91%.The flow rate of received sample was within the specification ±15% deviation from nominal flow rate.Summary of root cause analysis: since the flow rate of received sample was within the specification, hence we considered this complaint as not confirmed.Cause : cause could not be determine.The flow rate of received sample was within the specification after sent for flow rate test, which is according to test method 116008 under lab condition.Corrections/containment plans with effective date: not applicable.Corrective actions with effective date: not applicable.Justification: not confirmed.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.

• Brand Name: EASYPUMP® II
• Common Device Name: ELASTOMERIC INFUSION PUMP
• 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, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18794023
• Report Number: 9610825-2024-00110
• Device Sequence Number: 17928061
• Product Code: MEB
• UDI-Device Identifier: 04046964448515
• UDI-Public: (01)04046964448515
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• PMA/510(K) Number: K081905
• 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): 05/03/2024

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: 4540018-07
• Device Lot Number: 23F02GED71
• 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: 01/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown