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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
As per reported by the user facility: the solution on line 20 changed from sodium phosphate to potassium phosphate in the apex system.There was no patient involvement.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The logs were provided for evaluation.The logs show that sodium phosphate was confirmed on station 20 and later a potassium phosphate ndc was scanned and confirmed on station 20.It was found that the two (2) solutions were marked as interchangeable in the database.Apex will allow solutions that are marked interchangeable to be switched on the same station throughout the day and when reconciling an order would allow the ordered volume to be filled by either interchangeable ingredient.To fix this, the user needs to go into either the sodium phosphate ingredient or the potassium phosphate ingredient and undo the interchangeability between the two.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 75006 6690
• MDR Report Key: 11054671
• Report Number: 1641965-2020-00024
• Device Sequence Number: 2602478
• Product Code: NEP
• UDI-Device Identifier: 04046955048502
• UDI-Public: 04046955048502
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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: 12/10/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1