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

Model Number	AX1000
Medical Device Problem Code	Application Program Problem: Dose Calculation Error (1189)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: customer reported they performed the apex data update part 1 of the non-default data which changed some of the flow factors.The technicians reported certain solutions are running dry.There was no patient involvement.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The log review confirmed an occurrence of insufficient volume to complete the order.However, the customer provided additional information stating a return to normal and no further issues of this nature occurred.It was initially indicated a recent apex data update caused delivery factors to change, however, this only included updates to the occlusion bounds which would not affect the dispensing rates.A review of all suspect delivery factor barcodes was performed and the evidence shows that the ingredients had no changes provided to the customer between (b)(6) 2020 and the date of occurrence.This further suggests that the delivery factors or a change from the manufacturing process did not contribute to the source containers running dry.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: APEX
• Common Device Name: COMPOUNDER
• Manufacturer (Section D): B. BRAUN MEDICAL INC; 1601 wallace drive, suite 150; carrollton, tx
• MDR Report Key: 10219430
• Report Number: 1641965-2020-00010
• Device Sequence Number: 16671266
• Product Code: NEP
• UDI-Device Identifier: 04046955048502
• UDI-Public: 04046955048502
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 08/26/2020

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: AX1000
• Device Catalogue Number: AX1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1