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

Model Number	621-400ES
Medical Device Problem Code	Temperature Problem (3022)
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 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 per reported by the user facility: pump began to smoke and there was black charring around the outlet.No injuries were reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The device involved was received for evaluation.Thermal tracing shows the event source as internal to the plug of the ac power cord (e30608) with the resultant heat/residue spreading out from the plug to the daisy chain outlet and into the pump itself (e36935) and onto the housing of e26027.The event source is seen in the cavity that was formed between the contacts of the ac power cord.The plug of the ac power cord remained shorted under load during testing.The following is a summary of the information provided by our engineering team regarding the pump's flammability rating information: the device material is confirming with clause 55dv.4.1 of standard 60601-1 for flammability rating.No additional testing was needed on the plastic enclosures as the material and molder are approved for these requirements.Material is bayblend fr-110 as per our specifications.This material is listed with a ul94 flame rating of 5vb for 0.79" (2mm) thick (burning stops within 60 seconds on a vertical specimen; no drips allowed; plaque specimens may develop a hole) and 5va for.118" (3mm) thick.(burning stops within 60 seconds on a vertical specimen; no drips allowed; plaque specimens may not develop a hole).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: 11782821
• Report Number: 1641965-2021-00007
• Device Sequence Number: 19878913
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2021

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: 04/27/2021
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1