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

Catalog Number	AX1000
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The device logs and the transfer set have 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: bubbles were noticed on line 21.During re-priming of the line it was observed that the manifold was sucking fluid (mvi) from the manifold's common fluid path up through the source tubing towards the source solution on port 21.The pump was immediately stopped and the bag was scrapped.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 and the transfer set were received for evaluation.A review of the software logs indicates the user was attempting to prime line 21 numerous times.There was either no weight or very minimal weight being added to the scale.This was likely due to bubbles.Both lines 21 and 15 were primed in succession.This indicates that the user may have been experiencing either air in the line or a kink on line 21.The reason some residual infuvite (vitamin) may have been observed in line 21 is due to infuvite being present in the common volume due to the priming of line 15.Once the back pressure (or kink) was released from line 21, infuvite was able to be sucked (pulled) back into the line due to the vacuum generated from the priming process and the density of the two fluids, specifically, potassium phosphate and infuvite.This does not appear to be a defect of the transfer set or the device, but rather related to user influence or setup while priming.One used transfer set with packaging was returned for evaluation.Visual examination of the transfer set noted amber colored fluid present micro lines 21, 15, and 16.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 75006 6690
• MDR Report Key: 9279186
• Report Number: 1641965-2019-00015
• Device Sequence Number: 11308532
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2019

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 Catalogue Number: AX1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 12/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1