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)
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 (or device), 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 and no abnormality observed 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.
Additional Manufacturer Narrative
Exemption number e2016018.(b)(4).This report has been identified as b.Braun (b)(4) internal report # (b)(4).We received one used, empty easypump ii st 50-1-s without packaging.The provided sample was subjected to a visual examination.Damages or manufacturing faults were not detected at the pump.As described by the customer the easypump finished the administration before the set time (in 30 minutes instead of 60).In addition the sample was filled up to the nominal value (50 ml) and a functional test respectively a leak test was carried out.After opening the clamp clip the pump did work immediately (solution was running).Leakages were not detected.Furthermore the flow rate of the pump was tested.Nominal: 50 ml/h.Actual: 27 ml in 30 min; 40 ml in 45 min; 49 ml in 1 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.The inspected pump is within our specifications.Device history record (dhr): reviewed the dhr and no abnormality observed during in process and at final control inspection.

• 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: 7535402
• Report Number: 9610825-2018-00088
• Device Sequence Number: 1652719
• Product Code: MEB
• UDI-Device Identifier: 04046964449000
• UDI-Public: (01)04046964449000(17)211001(10)16M27GE401
• 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,Followup
• Report Date (Section B): 08/13/2018
• Report Date (Section F): 08/13/2018

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: 10/01/2021
• Device Model Number: N/A
• Device Catalogue Number: 4540044V
• Device Lot Number: 16M27GE401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/22/2018
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2018
• Initial Date Received by Manufacturer: 04/25/2018
• Supplement Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 08/13/2018
• 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: 08/13/2018