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

Model Number	621-400ES
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device involved has not been received for evaluation and the investigation is ongoing at this time.The serial number provided does not match the product 621-400es.Attempts have been made to contact the customer for clarification, as well as if the pump or pump logs are available for evaluation.A follow-up will be submitted when the investigation results become available.
Event or Problem Description
As reported on medwatch (b)(4): patient was ordered an infusion of d10, total of a 321.5 ml bolus.The pump was found to have infused 500 ml, overinfusing the patient by 178.5 ml extra d10.The patient suffered no harm but required additional monitoring.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc internal report # (b)(4).Multiple attempts were made to obtain additional information as well as to obtain the device and/or the logs.The device involved was not received for evaluation and the pump logs were not received for review.Without the actual device or logs a thorough investigation could not be performed and no specific conclusions can be drawn.If additional pertinent information becomes available a follow-up report will be filed.

• 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: 6984845
• Report Number: 1641965-2017-00044
• Device Sequence Number: 497306
• Product Code: FRN
• UDI-Device Identifier: 04046964186554
• UDI-Public: (01)04046964186554
• 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,other,use
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2017

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/18/2017
• Supplement Date Received by Manufacturer: 10/18/2017
• Initial Report FDA Received Date: 10/27/2017
• Supplement Report FDA Received Date: 01/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 YR