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

Model Number	621-400ES
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.(b)(4).Neither the device involved nor the pump logs have been received for evaluation and the investigation is ongoing at this time.It should be noted the customer indicated if the pumps are unplugged from ac power and the battery reset they would work again.Customer also stated no errors could be found in the logs to explain why the pumps are initially freezing.Additional information provided from the customer also indicates the batteries were reset on all of the pumps and they are currently charging.All the pumps have been infusion tested and they all tested fine.At this time, attempts for further information and samples are being made.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: event 19 of 21: over a two day period, within a specific area of the hospital, a total of 21 pumps displayed an error message and then froze.Twenty-one separate mdrs are being filed for this event.It is known that 16 pumps were not in use during the event; however, there was limited information reported on the remaining 5 pumps.No patient injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report # (b)(4).The actual pump involved in the reported incident was not returned for evaluation.Without the actual device further evaluation is not possible and no specific conclusions can be drawn.It is known that the pump's battery was removed and replaced at the user facility.There was no information provided indicating the error that was displayed prior to being reset.If this event should occur in the future, b.Braun medical has requested that the customer not reset the pump.B.Braun has instructed the customer to silence the alarm on the pump by pushing the power button, leave the pump plugged in, and contact b.Braun medical to have a service technician come to the facility to inspect the pump.If the device and/or additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: OUTLOOK®
• Common Device Name: INFUSTION PUMP
• Manufacturer (Section D): B. BRAUN MEDICAL INC; 1601 wallace drive; suite 150; carrollton TX 75006 6690
• MDR Report Key: 6864812
• Report Number: 1641965-2017-00038
• Device Sequence Number: 13481850
• Product Code: FRN
• UDI-Device Identifier: 04046964186547
• UDI-Public: (01)04046964186547
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/05/2017

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: 09/05/2017
• Supplement Date Received by Manufacturer: 09/05/2017
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1