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

Catalog Number	363219
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).One used set was received for evaluation.The set was tested for leakage per the specification with passing results.There was no leakage observed from the blood filter area.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.Based on the results of this investigation, no specific conclusions can be made regarding the cause of the reported event.However, due to this complaint and other confirmed complaints of this nature, b.Braun medical has initiated a corrective action/ preventative action (capa) (b)(4) to address the issue of leakage involving the bonded joint of the blood filter housing.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.Note: this case is being filed retrospectively as a result of a review of recent customer complaint information.Based on additional information and details provided in another complaint case, it was determined that this case is reportable in accordance with the requirements of 21 cfr 803.B.Braun has conducted a retrospective review for all complaints of a similar nature in accordance with internal procedure (b)(4).
Event or Problem Description
As reported by user facility: event 3: blood leaking around the blood filter.

• 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: 6124596
• Report Number: 9614279-2016-00178
• Device Sequence Number: 16339427
• Product Code: FPA
• UDI-Device Identifier: 04046964294372
• UDI-Public: (01)04046964294372(17)191231(10)0061411536
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/16/2015

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: 12/31/2019
• Device Catalogue Number: 363219
• Device Lot Number: 0061411536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2015
• Initial Report FDA Received Date: 11/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1