MAUDE Adverse Event Report: B. BRAUN MEDICAL INC APEX¿; COMPOUNDER

Model Number	601224
Medical Device Problem Code	Application Program Problem: Dose Calculation Error (1189)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).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 user facility: customer reported they had added the new smoflipid to their scdm database earlier in the day but the compounder was not pumping the correct amount for the patient order.The compounder was pumping water instead of the smoflipid solution.No patient involvement.
Event or Problem Description
As per user facility: customer reported they had added the new smoflipid to their scdm database earlier in the day but the compounder was not pumping the correct amount for the patient order.The compounder was pumping water instead of the smoflipid solution.No patient involvement.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).No logs or files were returned for evaluation.To determine a potential root cause a copy of the database or the patient file is required and therefore the event cannot be confirmed.This is likely an issue with the customer's setup of the database or how the patient file (.Pat) was generated.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: APEX¿
• Common Device Name: COMPOUNDER
• Manufacturer (Section D): B. BRAUN MEDICAL INC; 1601 wallace drive, suite 150; carrollton TX 75006 6690
• MDR Report Key: 8955177
• Report Number: 1641965-2019-00014
• Device Sequence Number: 2088383
• Product Code: NEP
• UDI-Device Identifier: 04046964801068
• UDI-Public: (01)04046964801068
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2019

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: Health Professional
• Device Model Number: 601224
• Device Catalogue Number: 601224
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 10/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1