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 Consequences Or Impact To Patient (2199)
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 two used, empty easypump ii lt 125-25-s without packaging.The provided samples were subjected to a visual examination.As-received condition the clamp clips were closed and the patient connectors were closed with a red combi stopper (the original wing cap was not handed over by the customer).Damages or other deviations were not detected.At the samples we detected crystallized drug residues at the filling port (lli-cone).Solution or crystallized drug residues in the lla-cone were not detected.Afterwards the pumps were 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 pumps the pumps did work immediately (solution was running).Leakages were not detected.In addition the flow rate of the pumps were tested.Nominal: 5 ml/h actual: sample 1: 7.4 ml in 1 h; 13.1 ml in 2 hrs; 90.3 ml in 18 hrs.Sample 2: 4.9 ml in 1 h; 10.0 ml in 2 hrs; 85.4 ml in 18 hrs.The values are within the specification.A fast flow (as described by the customer) could not be determined at the inspected samples.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 germany): 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: 6440627
• Report Number: 9610825-2017-00058
• Device Sequence Number: 13566663
• Product Code: MEB
• UDI-Device Identifier: 04046964448454
• UDI-Public: (01)04046964448454(17)210501(10)16F14GE211
• 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: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2017
• Report Date (Section F): 03/28/2017

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: 03/22/2017
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2017
• Initial Report FDA Received Date: 03/28/2017
• 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: 03/28/2017