MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. APEX¿; SYSTEM/DEVICE, PHARMACY CO

Model Number AX1000

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

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

Event Date 01/26/2022

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).The transfer set involved has been received for evaluation.Device evaluation not yet completed.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: it was observed the transfer set had what appears to be residue in it from the lipids used that day in production.No injuries were reported.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).The transfer set involved has been received for evaluation.Device evaluation not yet completed.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: it was observed the transfer set had what appears to be residue in it from the lipids used that day in production.No injuries were reported.

Manufacturer Narrative

This report has been identified as b.Braun medical, inc.Internal report (b)(4).The actual device involved in the reported incident was not returned for evaluation.R&d investigation show that the logs are incomplete.Both folders in b.Docs have the same log files, which only go until 11:40am on jan24th, and do not show any compounded orders or even any dispenses at all.The issue was reported that "at the end of production that day when the final patient order had completed, the staff noticed what appeared to be residue left over from the lipids hung that day" since there are no compounded orders, there is nothing close to the time that they were concerned about residual lipids.All that can be seen is that they pass leak check on the first attempt, and what their template initially was (though they might have modified it by the time the issue occurred) with the knowledge that the sequence might have changed, and without knowing the details of the order that may have caused issues, some notes on the default template sequence: 1) there is no indication that the template is not ideal for lipid residue.Lipid is not pumping last, swfi comes after it.2) if there was concern about the visible residue being ca/phos interaction instead of lipid, they have a ui buffer on kphos and naphos to begin the day.This means that there should be adequate separation of ca/phos to minimize any possible interaction.Again, these buffers could have been removed later in the day.At this point (4/11/2022) , if the logs haven't been gathered or retained by vanderbilt, the system would have cleared them because the panel only stores the last 60 days of software logs.

• Brand Name: APEX¿
• Type of Device: SYSTEM/DEVICE, PHARMACY CO
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 1601 wallace drive, suite 150; carrollton TX 75006 6690
• Manufacturer (Section G): B. BRAUN MEDICAL INC; 1601 wallace drive, suite 150; carrollton TX 75006 6690
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 13578760
• MDR Text Key: 285952564
• Report Number: 2523676-2022-00030
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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