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

Model Number	621-400ES
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 reported by the user facility: a nurse hung a 100cc bag of insulin as a secondary infusion and programmed the pump to run at 10cc/hour.The nurse went back 30 minutes later and the entire bag had infused.No patient injury.
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.Three (3) volumetric tests of 120ml/hr and 10ml were performed and tested within specification: 1st test: 9.93ml or 99% of expected volume, 2nd test: 9.84ml or 98% of expected volume, 3rd test: 9.86ml or 98% of expected volume.Based on the results of the investigation, the pump operated as intended.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: 9699693
• Report Number: 1641965-2020-00001
• Device Sequence Number: 3147587
• Product Code: FRN
• UDI-Device Identifier: 04046964186547
• UDI-Public: (01)04046964186547
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K011975
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2020

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: 621-400ES
• Device Catalogue Number: 621-400ES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1