MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. OUTLOOK®; PUMP, INFUSION

Model Number	621-200ES
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The device involved has not been received for evaluation and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As per the user facility: the pump was smoking from the back.The pump was attached to a patient at the time but no patient injury occurred.
Event or Problem Description
As per the user facility: the pump was smoking from the back.The pump was attached to a patient at the time but no patient injury occurred.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The device was not returned.Without the actual device/logs a thorough investigation could not be performed and further evaluation is not possible.If the device and/or additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: OUTLOOK®
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 1601 wallace drive, suite 150; carrollton TX 75006 6690
• MDR Report Key: 7845485
• Report Number: 1641965-2018-00020
• Device Sequence Number: 11045236
• Product Code: FRN
• UDI-Device Identifier: 04046964186523
• UDI-Public: (01)04046964186523
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K994375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2018

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: 621-200ES
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other