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	Skin Irritation (2076)
Date of Event	06/30/2017
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, empty easypump ii st 400-4-s without packaging.The provided sample was subjected to a visual examination.After opening the big white top cap and removing the closing cone, we detected solution (liquid) at the filling port (lli-cone).Furthermore we detected a crack in the li-cone of the filling port.Moreover, the pump was taken to a functional test respectively to a leak test.Therefore the pump was refilled with approximately 400 ml nacl 0.9 %.After starting the pump and waiting for 60 minutes the pump did work immediately.After these 60 minutes leakages were not detected.In addition, the flow rate of the pump was tested.Nominal: 100 ml/h actual: 145.6 ml in 1h; 271.6 ml in 2 hrs and 380.0 ml in 3 hrs (75 % of the total running time).With regard to the flow rate the inspected pump is not in accordance with our requirements as well with regard to the crack in the filling port.Device history records (dhr): reviewed device history records, there is no abnormalities and no such defect detected during 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: 6762256
• Report Number: 9610825-2017-00153
• Device Sequence Number: 11155671
• Product Code: MEB
• UDI-Device Identifier: 04046964449239
• UDI-Public: (01)04046964449239(17)211101(10)16N22GE471
• Combination Product (Y/N): N
• 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): 07/04/2017
• Report Date (Section F): 08/02/2017

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: 11/01/2021
• Device Model Number: N/A
• Device Catalogue Number: 4540058
• Device Lot Number: 16N22GE471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/02/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2017
• Initial Report FDA Received Date: 08/02/2017
• 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: 08/02/2017