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

Model Number 601224

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

Patient Problem No Patient Involvement (2645)

Event Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device logs have been received.The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Event Description

As per user facility: customer reported an encounter an issue were when the universal ingredient (ui) is selected to be something other than water and the container is changed during a manifold flush the software changes the ui to line 1 water.In this case the ui was line 3 trophamine and it changed to line 1 water when the trophamine container was changed.The ui was changed back to trophamine by the operator and compounding was able to continue.No patient involvement.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).The software issue has to do with scanning the source line barcode from the main screen to bring up the "replace container" screen for the current universal ingredient.When this is done in the middle of an order (only possible if user first presses "pause"), then the universal ingredient will revert from whatever station is was (2 or 3) to station 1.The final flush of the order will be performed with sterile water from station 1 instead of the intended universal ingredient.This will result in less volume of the intended universal ingredient in the amount of the flush volume and more of station 1 (water) than intended in the amount of the flush volume.Some of this flush volume will not make it into the final container, as it will be used to fill the manifold for the next order.Also, a manifold flush will be required prior to that next order.Additionally, the compounding activity report will show incorrect values for both delivered volume and ordered volume, neither will reflect the intended ordered volume.There is an active apex software project to address this issue.If additional pertinent information becomes available a follow-up report will be filed.

Event Description

As per user facility: customer reported an encounter an issue where when the universal ingredient (ui) is selected to be something other than water and the container is changed during a manifold flush the software changes the ui to line 1 water.In this case the ui was line 3 trophamine and it changed to line 1 water when the trophamine container was changed.The ui was changed back to trophamine by the operator and compounding was able to continue.No patient involvement.

Manufacturer Narrative

An additional information request was received for this report number.On 09apr2020, two (2) attempts were made to send the response to the email address provided in the request, (b)(6).However, rejection emails were received that stated (b)(6) wasn't found at fda.Hhs.Gov.Therefore, this mdr follow-up is being generated to provide the reponse to the additional information request.Please see the attached documents.To note, a hardcopy response was also sent via mail to the address listed in the request on 10apr2020.

• Brand Name: APEX
• Type of Device: COMPOUNDER
• Manufacturer (Section D): B. BRAUN MEDICAL INC; 1601 wallace drive, suite 150; carrollton TX 75006 6690
• MDR Report Key: 8508402
• MDR Text Key: 141750718
• Report Number: 1641965-2019-00008
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 04046964801068
• UDI-Public: (01)04046964801068
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 601224
• Device Catalogue Number: 601224
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1