MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INFUSOMAT®; PUMP, INFUSION

Catalog Number	8713060U
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2016018 b.Braun inc.(bbmi) (importer) is submitting the report on behalf of b.Braun melsungen ag (manufacturer).This report has been identified as b.Braun medical inc.Internal report number (b)(4).The investigation into this reported event is ongoing.A follow-up report will be submitted when the results of the investigation are available.
Event or Problem Description
As reported by user facility: gammagaurd was set to infuse in 2 hours, but the infusion took 5 hours.The customer said this has happened more than once, but did not have any additional details.No patient injury.
Additional Manufacturer Narrative
Exemption number e2016018.(b)(4).This report has been identified as b.Braun medical inc.Internal report number (b)(4).Failure analysis and investigation results did not confirm the reported issue.Upon receipt the actual pump involved was visually and functionally inspected.Three (3) volumetrics of 250 ml/hr and 25ml were performed and tested in spec.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.The pump operated as intended and the reported failure could not be reproduced.Based on the results of the investigation, no conclusions can be made regarding the cause of the reported event.If additional information becomes available, a follow up report will be submitted.

• Brand Name: INFUSOMAT®
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 6977636
• Report Number: 9610825-2017-00209
• Device Sequence Number: 16395102
• Product Code: FRN
• UDI-Device Identifier: 04046963687199
• UDI-Public: (01)04046963687199
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K083689
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2017
• Report Date (Section F): 11/30/2017

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 Catalogue Number: 8713060U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 6 YR
• Date Report to Manufacturer: 11/30/2017
• Initial Date Received by Manufacturer: 10/11/2017
• Supplement Date Received by Manufacturer: 10/11/2017
• Initial Report FDA Received Date: 10/25/2017
• Supplement Report FDA Received Date: 11/30/2017
• 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: 11/30/2017