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

Model Number	621-100ES
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device involved is pending 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 reported by the user facility: while infusing, the pump was found to have smoke coming from the pump itself and it was hot to the touch.The infusion was stopped.It was indicated there was a small amount of smoke observed at the back of the pump with a burnt electrical odor.Vancomycin 1 gram reconstituted in 250ml of 0.9% sodium chloride was infusing at the time.The volume to be infused was 250ml at a rate of 167ml/hr.There was no injury to the patient.
Additional Manufacturer Narrative
(b)(4).The device involved was received for evaluation.The incoming battery measured 1.6v.The failed 12v battery was replaced.The log review shows on (b)(6) 2018 and 9:23am a dc power-on and at 9:28am an infusion start of 167ml/hr and 264ml.At 9:28am a low battery warning occurred.On (b)(6) 2018 and 6:01am the pump powered-on with se 75, 123, indicating a previous unexpected pump power down.If additional pertinent information becomes available a follow-up report will be filed.
Event or Problem Description
As reported by the user facility: while infusing, the pump was found to have smoke coming from the pump itself and it was hot to the touch.The infusion was stopped.It was indicated there was a small amount of smoke observed at the back of the pump with a burnt electrical odor.Vancomycin 1 gram reconstituted in 250ml of 0.9% sodium chloride was infusing at the time.The volume to be infused was 250ml at a rate of 167ml/hr.There was no injury to the patient.

• Brand Name: OUTLOOK®
• Common Device Name: INFUSION PUMP
• Manufacturer (Section D): B. BRAUN MEDICAL INC; 1601 wallace drive, suite 150; carrollton TX 75006 6690
• MDR Report Key: 7447683
• Report Number: 1641965-2018-00003
• Device Sequence Number: 11204762
• Product Code: FRN
• UDI-Device Identifier: 04046964186516
• UDI-Public: (01)04046964186516
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2018

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: 621-100ES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/25/2018
• Supplement Date Received by Manufacturer: 03/25/2018
• Initial Report FDA Received Date: 04/20/2018
• Supplement Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1