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

Model Number AX1000

Device Problems Device Alarm System (1012); Device Difficult to Program or Calibrate (1496); Failure to Align (2522)

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

Event Date 11/17/2022

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 the manifold was observed raising off the pump and failed the valve check exercise and leak check.A new transfer set from a different lot was installed and the leak check passed.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).One used sample with packaging was returned for evaluation.Sample was evaluated by sme due to valve check failure during setup of the device in the field.A torque test was performed on the micro and macro valves of the manifold assay and it was found that multiple valves were at the upper end of the specification for torque.Samples were submitted to the qc analytical lab to perform ftir testing on the valves and it was found there was no silicone present.This inefficient solvent being present led to the high values being seen for torque testing.Due to the inefficient solvent, the sample fails evaluation.The defect is confirmed due to inefficient silicon on the valves.Based on the supplier's investigation, it was found that the device history record (dhr) only has one step noting the quantity of bags per lot; this step is completed by the operator of the siliconization operation.Also, the bag used for the siliconization step has leaked a few times but has not immediately been detected by the operator (it is unknown on which lots of these leaks occurred).The leak can occur on the work surface or inside the tumbler, which reduces the amount of acetone/silicone inside the poly bag with the parts.Based on the dhr review, it cannot be concluded that referenced complaint is manufacturing-related from the supplier's perspective.However, the supplier will investigate the two opportunities described above for improvements to their process.One retain sample was tested for torque of the micro and macro valves with failing results.Due to failing results of the retain, before and after lots of this house retain will be pulled for evaluation.The before and after lots were dyne tested for silicone with passing results.The defect on the before and after lots is not confirmed.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• 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: 15979317
• MDR Text Key: 306331695
• Report Number: 2523676-2022-00600
• 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: 07/31/2023

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: 11/17/2022
• Initial Date FDA Received: 12/14/2022
• Supplement Dates Manufacturer Received: 11/17/2022
• Supplement Dates FDA Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2018
• 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