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	10/04/2017
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.A follow-up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: the starting volume was 1 liter.The nurse programmed the pump to infuse 533 ml over 45 minutes.She then reprogrammed the pump to infuse at a rate of 114 ml/hr for the remaining volume.The pump alarmed "volume infused" 3 hours into the second infusion (total run time 4 hr 12 min).The pump displayed "pump needs repair".The customer was unable to share what was being infused, but they did provide that there was no patient injury.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc internal report # (b)(4).The reported complaint was not confirmed.Volumetrics run of 533.3ml/hr and 400ml tested in spec at 396ml or 99% of expected volume.Volumetrics run of 114ml/hr and 159.1ml tested in spec at 158ml or 98% of expected volume.Furthermore, the pump's operational log was reviewed and there were no indications that the pump malfunctioned.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: INFUSION PUMP
• Manufacturer (Section D): B. BRAUN MEDICAL INC; 1601 wallace drive, suite 150; carrollton TX 75006 6690
• MDR Report Key: 6958515
• Report Number: 1641965-2017-00041
• Device Sequence Number: 745779
• Product Code: FRN
• UDI-Device Identifier: 04046964186547
• UDI-Public: (01)04046964186547
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/11/2017
• Supplement Date Received by Manufacturer: 10/11/2017
• Initial Report FDA Received Date: 10/18/2017
• Supplement Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR