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

Model Number	601223
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	01/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event 2: 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 reported by the user facility: event 2: customer has received complaints that their tpn bags are running out before they should.This occurred with two (2) patients.This report is for patient #2, neonate patient.Customer reported that all bags that ran dry had total expected weight to total weight variances of 1% to 1.5%.Some of the variances in total weight were overweight and some were underweight.There was no harm caused to the patient.
Additional Manufacturer Narrative
Event 2: this report has been identified as b.Braun medical inc.Internal report number (b)(4).No sample or device logs were returned in connection with this complaint.Compounding activity reports (car) were provided, however, there is no way to link the exact car to the bag that ran dry.Therefore, the root cause of this event could not be determined.Based on the information provided and the investigation, it appears that the delivery from apex only under-dispensed at most a -1.44% variance weight.In addition, occlusion bounds are in place to ensure accuracy up to a certain point on each individual dispense, and no over-ridden occlusions were observed in the provided compounding activity reports.If additional pertinent information becomes available a follow-up report will 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: 9699315
• Report Number: 1641965-2020-00003
• Device Sequence Number: 1877855
• Product Code: NEP
• UDI-Device Identifier: 04046964801051
• UDI-Public: (01)04046964801051
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2020

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: 601223
• Device Catalogue Number: 601223
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 04/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1