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	08/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The device logs and the transfer set have not been received for evaluation.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 that the pump ran fine for the majority of the day.During troubleshooting for occlusions the lines were reprimed and a manifold flush was done.After the sterile water on line 1 was finished pulling for the flush, it was observed that lipids were being pushed through the transfer set tubing.The lipids being used were smof lipid 20% on line 25 (macro) and nutrilipid on line 26 (macro).When the transfer set was removed it was noticed that the valve on the transfer set manifold on line 25 (smof lipid 20%) was stuck in an open position.There were visible markings on the valve that were indicative of an attempt to close but failed to do so.There was no patient involvement.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).One (1) used transfer set was returned for evaluation.Visual examination of the 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 is not a manufacturing defect.The device logs were reviewed and showed the transfer set ran normally for most of the day (about 7 hours) with normal dispenses from all stations including station 25.Pressure values for station 25 were normal and typical throughout the day as well.During the final dispense of fluid from station 25, the valve attempted to close and caused the manifold to become unlatched.The sensor values were immediately impacted which triggered an alert to the user and the apex stopped.The transfer set was removed and station 25 was in an open state.It is possible the user may have improperly latched the manifold onto the compounder and while compounding, the manifold became detached and halted compounding.A retained transfer set 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.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: 10447443
• Report Number: 1641965-2020-00015
• Device Sequence Number: 14333810
• 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): 10/02/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1