MAUDE Adverse Event Report: B. BRAUN DOMINICAN REPUBLIC INC. INFUSOMAT®; SET, ADMINISTRATION, INTRA

Catalog Number	363423
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Two used sets were received for evaluation.In an attempt to replicate the reported event, the returned sets were primed and loaded into an infusomat space pump per the instructions for use.The pump ran for ten minutes at 400ml/hr.During this time, there were no air bubbles observed in any location of the tubing sets and the pump did not alarm any errors.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 or lot number.Based on the results of this investigation, no specific conclusions can be made regarding the cause of the reported event.The returned set met requirements according to specification, and the reported failure could not be reproduced.If additional pertinent information becomes available a follow-up report will be filed.(b)(4).
Event or Problem Description
As reported by user facility: finding air bubbles in line, near the silicone pump segment.

• Brand Name: INFUSOMAT®
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN DOMINICAN REPUBLIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, dominican republic ; DR
• MDR Report Key: 6134563
• Report Number: 9614279-2016-00079
• Device Sequence Number: 161840
• Product Code: FPA
• UDI-Device Identifier: 04046964294655
• UDI-Public: (01)04046964294655(17)180714(10)0061445936
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K142036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/07/2015

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: 07/14/2018
• Device Catalogue Number: 363423
• Device Lot Number: 0061445936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2015
• Initial Report FDA Received Date: 11/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1