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

Catalog 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 11/26/2022

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical 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 reported by the user facility: we had an issue over the weekend where a provider updated the volume for lipids, and the infusion period updated instead of the infusion rate.Can you please investigate to see if the provider incorrectly modified this field or if the apex software made the change? rev c does not process the data correctly on the 1st attempt, rev d would have updated correctly.No patient injury reported.

Manufacturer Narrative

The report has been identified as b.Braun medical, inc.Internal report (b)(4).The device was not returned for evaluation.Further investigation of the complaint is not possible without a device.If the device does become available, the complaint will be reopened for further evaluation.All information concerning this reported incident has been included in our trend analysis of the product line.

• Brand Name: APEX®
• Type of Device: COMPOUNDER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 1601 wallace drive; suite 150; carrollton TX 75006
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 1601 wallace drive; suite 150; carrollton TX 75006
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4047197287
• MDR Report Key: 16054974
• MDR Text Key: 308448471
• Report Number: 2523676-2022-00603
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 601238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1