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 Known Impact Or Consequence To Patient (2692)
Date of Event	04/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device involved was not returned for evaluation.The b.Braun sales representative provided an overview of what configuration settings were available in both the customer's outlook400 units, as well as their outlook400es units.After discussing all available options, the customer chose to select the "clear all" settings, in their biomed setup.This will insure that when they turn their pumps off and on again, the previously programmed medications will be cleared upon start up.At that point the facility's biomed made the change to both of the different versions of devices to the "clear all" all setting.Biome proceeded to upload the new configuration to all of their units manually.If additional pertinent information becomes available a follow-up report will be filed.
Event or Problem Description
As per reported by the user facility: they recently had a medication error in the emergency department that resulted from their current iv pump programming.The pumps are currently set to default back to whatever had been previous programmed and pull in information, like the patient's weight, when they are first turned on to start an infusion.As a result, we had a (b)(6) kg patient that accidently received a medication dosed at a weight of (b)(6) kg, potentially under-dosing them.The patient was administered propofol.No patient injury.

• 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: 8595932
• Report Number: 1641965-2019-00010
• Device Sequence Number: 1639415
• Product Code: FRN
• UDI-Device Identifier: 04046964186547
• UDI-Public: (01)04046964186547
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 05/09/2019

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
• Device Catalogue Number: 621-400ES
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 99