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

Model Number	N/A
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2016018 b.Braun medical, inc.(importer) is submitting this report on behalf of b.Braun melsungen ag (manufacturer).This report has been identified as b.Braun melsungen ag internal report # (b)(4).We received one used easypump ii lt 125-25-s without packaging.The provided sample was subjected to a visual examination.Damages or other defects were not detected at the sample.In addition the sample was filled up to the nominal value (125 ml) and a functional test respectively a leak test was carried out.After opening the clamp clip and starting the pump, the pump worked immediately (solution was running).Leakages were not detected.Furthermore the flow rate of the pump was tested.Nominal: 5 ml/h actual: 6.0 ml in 1 h; 13.6 ml in 2 hrs; 84.6 ml in 19 hrs.The measured values are within our specifications.A too fast flow (as described by the customer) could not be determined at the inspected sample.Device history record (dhr): reviewed the dhr of the complaint batch, there is no abnormality and similar defect detected at in process and at final control inspection.
Event or Problem Description
As reported by the user facility (translation of user facility information by bbm sales organization in germany): solution / fast flow.

• 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
• MDR Report Key: 8130335
• Report Number: 9610825-2018-00255
• Device Sequence Number: 16206358
• Product Code: MEB
• UDI-Device Identifier: 04046964448454
• UDI-Public: (01)04046964448454(17)221201(10)18A01GE211
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K081905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 12/04/2018
• Report Date (Section F): 12/04/2018

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 Expiration Date: 12/01/2022
• Device Model Number: N/A
• Device Catalogue Number: 4540006
• Device Lot Number: 18A01GE211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/04/2018
• Device Age: 11 MO
• Event Location: Other
• Date Report to Manufacturer: 12/04/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 12/04/2018