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

Model Number AX1000

Device Problem Application Program Problem: Dose Calculation Error (1189)

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

Event Date 06/12/2023

Event Type  malfunction  

Event Description

As reported by the user facility: customer reported 1 specific order was compounded 7 times, 6 were successful, 1 was scrapped due to final container being cloudy.No lipids were in this order.

Manufacturer Narrative

This report has been identified as b.Braun medical, inc.Internal report number (b)(4).The device was not returned for evaluation.The logs were provided for review.The log review did note the occurrence of the reported issue.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; carollton TX 75006 6690
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 1601 wallace drive; suite 150; carollton TX 75006 6690
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 17308465
• MDR Text Key: 318893134
• Report Number: 2523676-2023-00324
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 04046955048502
• UDI-Public: (01)04046955048502
• Combination Product (y/n): N
• 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
• Report Date: 07/12/2023

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
• Device Operator: Health Professional
• Device Model Number: AX1000
• Device Catalogue Number: AX1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2023
• Initial Date FDA Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2016
• 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