MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG B. BRAUN; INFUSION PUMP MANAGEMENT UNIT, MOBILE

Model Number	N/A
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2018
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.It should be noted that although the spacestation itself cannot deliver an infusion, this report is being filed because a malfunction of the device could have contributed to the event.If the sample and/or additional pertinent information becomes available, a follow up report will be submitted.
Event or Problem Description
As reported by the user facility (translation of user facility information by bbm sales organization in finland): underinfusion.
Additional Manufacturer Narrative
Exemption number e2016018.(b)(4).No sample was sent in for an investigation.Therefore, an analysis for a possible root cause was not possible.The complaint is considered as not confirmed.

• Brand Name: B. BRAUN
• Common Device Name: INFUSION PUMP MANAGEMENT UNIT, MOBILE
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-strasse 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 7644035
• Report Number: 9610825-2018-00117
• Device Sequence Number: 2413224
• Product Code: FRN
• UDI-Device Identifier: 04046963716769
• UDI-Public: (01)04046963716769
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K062700
• 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): 09/27/2018
• Report Date (Section F): 09/27/2018

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 Model Number: N/A
• Device Catalogue Number: 8713140
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/26/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/27/2018
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 06/27/2018
• Supplement Report FDA Received Date: 09/27/2018
• 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: 09/27/2018