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

Model Number	US3140
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).One used outlook pump tubing set was received for evaluation.Packaging returned with the set indicated the reported lot number.The set was subjected to leakage testing according to our internal specification.During this testing, leakage was observed at the sonic weld seal of the magnetic well pillow of the cassette pump segment.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or involved outlook cassette component and lot numbers.However, bbmi has shared this reported event with all applicable supervisors and personnel involved with the manufacturing and inspection of this product to ensure awareness of this event and failure mode reported from the field.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.If additional pertinent information becomes available, a follow-up report will be filed.
Event or Problem Description
As reported by the user facility: reports the pump alarms air in line multiple times.The nurses try to re-prime the line, but pump continues to alarm for air in line.Upon inspection of the tubing set, a small hole was observed near the metal pump segment and leakage was noted.Antibiotic medication was being infused at the time.The patient did not receive the total dose and was exposed to air in line.Once the tubing was changed, there were no further air in line alarms or leakage there were no patient injuries.

• Brand Name: OUTLOOK®
• 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: 6118063
• Report Number: 9614279-2016-00085
• Device Sequence Number: 323244
• Product Code: FPA
• UDI-Device Identifier: 04046964183034
• UDI-Public: (01)04046964183034(17)170731(10)0061388610
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K904518
• 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): 12/18/2014

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: 07/31/2017
• Device Model Number: US3140
• Device Catalogue Number: 375196
• Device Lot Number: 0061388610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2014
• Initial Report FDA Received Date: 11/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1