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

Model Number	601238
Medical Device Problem Codes	Labelling, Instructions for Use or Training Problem (1318); Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
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 reported by the user facility: the infusion rate on the label is not updating appropriately after updating the patient's weight.When the provider updates the patient's weight but does not change the ml/kg infusion volume, the total infusion volume (ml) appropriately changes, however the ml/hr infusion rate does not update.There was no patient involvement.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).This is an anomaly in the software where the patient weight changes on /kg orders do not automatically force a re-calculation of the infusion rate.This can lead to an incorrect infusion rate being printed on the final container label.This software anomaly will be addressed in apex project 20200211.The workaround is, after changing the rate, any orders that are not yet authorized should have their rate deleted and then submit changes to re-calculate the rate.It will then re-calculate the rate correctly.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: 11404067
• Report Number: 1641965-2021-00005
• Device Sequence Number: 4274978
• Product Code: NEP
• UDI-Device Identifier: 04046955589531
• UDI-Public: 04046955589531
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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): 04/26/2021

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: 601238
• Device Catalogue Number: 601238
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1