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

Model Number	601224
Medical Device Problem Code	Application Program Problem: Dose Calculation Error (1189)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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.
Additional 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
• Common Device Name: COMPOUNDER
• Manufacturer (Section D): B. BRAUN MEDICAL INC; 1601 wallace drive, suite 150; carrollton TX 75006 6690
• MDR Report Key: 8508402
• Report Number: 1641965-2019-00008
• Device Sequence Number: 1524955
• Product Code: NEP
• UDI-Device Identifier: 04046964801068
• UDI-Public: (01)04046964801068
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2020

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
• Operator of Device: Health Professional
• Device Model Number: 601224
• Device Catalogue Number: 601224
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 04/08/2019; 04/08/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 05/29/2019; 04/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1