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

Model Number 601238

Device Problems Labelling, Instructions for Use or Training Problem (1318); Data Problem (3196)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2021

Event Type  malfunction  

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 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.

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
• Type of Device: COMPOUNDER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 1601 wallace drive, suite 150; carrollton TX 75006 6690
• MDR Report Key: 11404067
• MDR Text Key: 241732200
• Report Number: 1641965-2021-00005
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 04046955589531
• UDI-Public: 04046955589531
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 601238
• Device Catalogue Number: 601238
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1