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	Nausea (1970)
Date of Event	10/18/2018
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).No sample has been returned for investigation.Without the actual sample, a thorough investigation could not be performed and no specific conclusion can be drawn as to the cause of the reported event.If the sample and/or additional pertinent information becomes available, a follow up report will be submitted.Device history record (dhr): reviewed the dhr, there is no abnormality and no such 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 france: pump-flow rate-fast.

• 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: 8025644
• Report Number: 9610825-2018-00233
• Device Sequence Number: 16495701
• Product Code: MEB
• UDI-Device Identifier: 04046964448454
• UDI-Public: (01)04046964448454(17)220701(10)17H25GE211
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2018
• Report Date (Section F): 10/31/2018

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: 07/01/2022
• Device Model Number: N/A
• Device Catalogue Number: 4540006
• Device Lot Number: 17H25GE211
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/31/2018
• Device Age: 14 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 10/31/2018
• 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: 10/31/2018