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

Model Number	4540008-02
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
Event or Problem Description
As reported by the user facility / translation of user facility information by bbm sales organization in (b)(6): "overinfusion" "reason of complaint: we've had another easypump returned to us yesterday where it was reported that it infused too quickly.Patient was connected at approx.1600 however easypump was found to be empty by the nurse at 1200pm next day.Patient's wife then reported that it was already empty at 0700.".
Additional Manufacturer Narrative
This report has been identified as b.Braun melsungen ag internal report (b)(4) the complaint is still under investigation.A follow-up report will be provided, as soon as investigation has been completed.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 Manufacturer Narrative
This report has been identified as b.Braun melsungen ag internal report # (b)(4).Received 1 used and filled easypump ii lt 270-27-s.As received condition, clamp clip of received sample was clamped.Patient connector of received sample was not connected to wing cap.Visual inspection had done throughout the sample.According to customer, the pump was emptied.However, during investigation, it was observed that there is remaining solution inside the easypump.There was still approximately 15ml of solution inside the pump.The sample was sent for flow rate test.The flow rate deviation from nominal flow rate for the received samples were -5.57% from nominal flow rate.The flow rate of received samples were within the specification ±15% deviation from nominal flow rate.Summary of root cause analysis: the sample was not emptied when received.Furthermore, the flow rate of received sample was within the specification, hence we considered this complaint as not confirmed.Received sample is within specification.Device history record (dhr): reviewed the dhr for batch 21d28ge221, there is no abnormality and no such defect detected at in process and at final control inspection.

• 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: 14053398
• Report Number: 9610825-2022-00128
• Device Sequence Number: 4642599
• Product Code: MEB
• UDI-Device Identifier: 04046964448485
• UDI-Public: (01)04046964448485(17)260401(10)21D28GE221
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 07/05/2022

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 Model Number: 4540008-02
• Device Catalogue Number: 4540008
• Device Lot Number: 21D28GE221
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown