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

Model Number	AX1000
Medical Device Problem Codes	Failure to Align (2522); Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2020
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 currently ongoing.A follow-up will be submitted when the investigation results become available.
Event or Problem Description
As per user facility: it was stated fluid from either port 25 (smof lipid) or port 26 (nutrilipid) is flowing backwards into the transfer set manifold.It is unknown which ingredient is flowing backwards.The transfer set was discarded.There was no patient involvement.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The device logs were obtained and reviewed.The logs show the transfer set is installed and pumping is fairly normal throughout the day.However, additional analysis indicates that the occlusion readings on both the macro and micro drift towards "less force on sensor" as the day goes on.It is theorized that this is an indication that the transfer set appears to have not been clipped-in fully on the right-hand side or became unclipped during compounding (most likely as valve 25 finishes pumping).The occlusion readings sharply drop off showing no force on the sensor.At that time, valve 5 pumps and an occlusion is received because of the unresponsive occlusion sensor.The occlusion signal becomes unresponsive due to the tubing no longer touching the sensor.As a result to no further occlusion reading responsiveness, the user takes the set off and notices valve 25 is turned.This could have happened if the transfer set popped off the right-hand side while valve 25 was closing.There were no alerts because the left-hand side was still clipped in, which is where the magnet which senses the transfer set resides.The transfer set used in this event was not returned for evaluation.However, a transfer set was returned in a similar case under b.Braun internal report (b)(4).Visual examination of that set noted that valve 25 was in an open position.The sample was leak tested per specification and it was noted that air was coming from the end of line 25.It was determined this issue was not a manufacturing defect.A retained transfer set of the same lot was visually inspected and no defects were noted.The retained transfer set was occlusion tested and vacuum leak tested per specification with passing results.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.It is possible the user may have improperly latched the manifold onto the compounder and while compounding, the manifold became detached and halted compounding.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: 10489274
• Report Number: 1641965-2020-00016
• Device Sequence Number: 4016457
• 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
• 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): 10/28/2020

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: No Information
• Device Model Number: AX1000
• Device Catalogue Number: AX1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1