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

Model Number AX1000

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

Patient Problem Electrolyte Imbalance (2196)

Event Date 01/03/2023

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 reported by the user facility: customer reported a tpn compounded at their facility is suspected to have had a potential compounding error during the apex process procedure.

Manufacturer Narrative

Thie report has been identified as b.Braun medical, inc.Internal report (b)(4).The logs of the device were provided for review.The log review did not note an occurrence of the reported issue.

• 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: 16358352
• MDR Text Key: 309428568
• Report Number: 2523676-2023-00036
• 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,Followup
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• 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
• Date Manufacturer Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2017
• 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