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

Model Number	621-400ES
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device involved has 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 had a burning smell with overheating.The top case was burned.No patient injury/involvement.The pump is operational but not repaired.There was no patient injury/involvement with this event.
Event or Problem Description
As per the user facility: the pump had a burning smell with overheating.The top case was burned.No patient injury/involvement.The pump is operational but not repaired.There was no patient injury/involvement with this event.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The device involved has been received for evaluation.The reported complaint of thermal damage was confirmed.The power supply had evidence of resistive current path between 16v and the ground connections that increased in temperature until the immediate area of the power supply board/connectors and case top were damaged.The power supply and the case top were replaced and preventive maintenance service was performed.If additional pertinent information becomes available a follow-up report will be filed.If 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: 7613028
• Report Number: 1641965-2018-00008
• Device Sequence Number: 1946537
• Product Code: FRN
• UDI-Device Identifier: 04046964186547
• UDI-Public: (01)04046964186547
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K011975
• 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,Followup
• Report Date (Section B): 07/25/2018

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: No Information
• Device Model Number: 621-400ES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/05/2018
• Supplement Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 07/25/2018
• 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