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 Known Impact Or Consequence To Patient (2692)
Date of Event	12/10/2019
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 b.Braun implementation specialist: customer was experiencing issues with their smoflipid source containers running dry, indicating overdelivery.There was a pediatric patient on a 3-in-1 tpm that included smof, whose tpn were at +4.9% overweight.The customer has their acceptable variance set to +/- 5%.They opted to send the bag out to the patient.There was no reported patient injury.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The root cause was attributed to accidental oversight due to the manual data entry process in the creation of delivery factors barcode sheet, and failure of secondary verification data review per procedure.When there is a request for new delivery factors from the customer, there is a lack of automation of data entry from the apex flow factors processor tool to the barcode generator tool, as these are two different and separate applications.Upon review of document evidence, the delivery factors for the intended ndc 63323-820-10 (smoflipid 20%) were based on the existing flow factors for a similar already created ndc of the same solution but different package.As no new development of flow factors was needed for the solution, the technical services representative attempted to copy the information from the existing ndc to the new ndc using the barcode generator tool, eventually creating the incorrect input.This resulted in the high speed flow factor on the macro channel reading 1.8050 instead of the desired 1.0805.Ultimately, smoflipid was unable to be flushed because the high speed flow factor was higher than the allowable system limit (1.3) due to the error.If apex gets a flow factor higher than the system limit, it produces a "pump communication error" and will not pump while also failing the bag.From review of the logs, it can be determined that this fast speed dispense must not have been used until an attempted flush, where the issue was first noted.Furthermore, a fast speed dispense will not be used if dispenses are < 150ml.As such, this incorrect flow factor would not have been used on a patient bag.Project 20200210 was initiated by b.Braun to revise the barcode generator and allow for automatic importing of the flow factor processor data into the generator tool, to reduce the likelihood of human error occurring when creating the delivery factors barcodes.As a countermeasure, delivery factor values for ndc 63323-820-10 (smoflipids 20%) were immediately corrected as of 12/9/2019 and distributed to the customer.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: 9558113
• Report Number: 1641965-2019-00017
• Device Sequence Number: 11423441
• Product Code: NEP
• UDI-Device Identifier: 04046955048502
• UDI-Public: (01)04046955048502
• 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
• Report Date (Section B): 05/28/2020

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: 12/10/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 05/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1