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

Model Number	621-400ES
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 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 pump stopped infusing on its own during a a patient infusion.It could not be clarified if there was a power failure, if someone hit stop or if it under-infused.The facility requested the event history and key stroke history be reviewed to determine why the pump stopped.No patient injuries were reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The device involved has been received for evaluation.The volumetric accuracy was tested three (3) times at 120ml/hr and 10ml and the unit tested in specification without interruptions or alarms: 1st test: 9.94ml or 99% of expected volume.2nd test: 9.87ml or 98% of expected volume.3rd test: 9.91ml or 99% 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: PUMP, INFUSION
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 1601 wallace drive, suite 150; carrollton TX 75006 6690
• MDR Report Key: 11278925
• Report Number: 1641965-2021-00002
• Device Sequence Number: 3383273
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2021

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: 02/02/2021
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1