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	03/04/2017
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, half filled easypump ii lt 125-25-s without packaging.The provided sample was subjected to a visual inspection.Damages were not detected.As-received condition the clamp clip was closed and the patient connector was not closed (the original wing cap was not handed over by the customer).Further on, we detected no liquid and crystallized drug residues at the filling port (lli-cone) and at the patient connector (lla-cone) of the sample.Additionally the pump was filled with nacl 0.9 % up to the nominal value (125 ml) and a functional test respectively a leak test was carried out.After starting the pump the pump did work immediately (solution was running).Leakages were not detected.Furthermore the flow rate of the pump was tested.Nominal: 5 ml/h actual: 7.8 ml in 1 h; 14.9 ml in 2 hrs; 83.8 ml in 16 hrs.The flow rate of the inspected pump is within our specifications.A too fast flow (as described by the customer) could not be determined.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: 6454000
• Report Number: 9610825-2017-00064
• Device Sequence Number: 13797493
• Product Code: MEB
• UDI-Device Identifier: 04046964448454
• UDI-Public: (01)04046964448454(17)210501(10)16F14GE211
• 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: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2017
• Report Date (Section F): 04/03/2017

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: 05/01/2021
• Device Model Number: N/A
• Device Catalogue Number: 4540006
• Device Lot Number: 16F14GE211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2017
• Initial Report FDA Received Date: 04/03/2017
• 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: 04/03/2017