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

Model Number	621-400ES
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 reported by the user facility: it was reported when doing preventive maintenance (pm) the volume was off by 10% and there were errors 93 and 86.No patient injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The device involved was received for evaluation and volumetrics testing was performed.The volumetrics runs was done at 120ml/hr and 10ml measured 8.9ml.The petal module was found to be broken and was replaced.The log review confirmed system errors 93 and 86.The main board was replaced to correct the system errors.If additional pertinent information becomes available a follow-up report will be filed.
Event or Problem Description
As per reported by the user facility: it was reported when doing preventive maintenance (pm) the volume was off by 10% and there were errors 93 and 86.No patient injury reported.

• 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: 8288802
• Report Number: 1641965-2019-00001
• Device Sequence Number: 2141044
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2019

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: 01/16/2019
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1