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

Model Number AX1000

Device Problem Improper Flow or Infusion (2954)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 01/12/2018

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).The device involved has not been received for evaluation and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Event Description

As per user facility: when initially priming port 7 (potassium chloride) occlusions were received.Customer was able to get past the occlusions after troubleshooting and power-cycling the pump.Upon priming port 19 (adult mvi), and priming very slow, it was noticed the port 7 micro side looked like it was being primed.A yellow tint was noticed in line 7.There were no crimps or kinks seen in the transfer set lines that would cause a possible back up of solution.It was indicated port 7 micro had potassium chloride coming down the line as if it were being primed and a tint of yellow mixed in.This would indicate port 7 valve may have been compromised causing the potassium chloride to come down the line and the mvi from port 19 (while being primed) to enter the compromised valve 7 and mix with the potassium chloride causing a yellow tint in the solution.It was immediately advised to replace the transfer set and scrap the bag.No patient involvement.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).Review of the logs did not indicate a leak during leak check, and leak check was not disabled.The user successfully primes every other station on flex, macro and micro channels except for one flex station.The user cannot prime one flex station on the micro side due to occlusions, despite trying over a dozen times.Eventually they notice, when a solution with obvious coloration is primed, that there is intermixing on the micro line that was occluding, and that it looks like the micro line that was occluding was pumping even when a different station was pumping.The transfer set was returned and the micro valve # 7 was confirmed to be 180 degrees out of phase, therefore leading to occlusions and the potential for cross contamination.The investigation into the reported issue confirmed that it is possible to have a partially misaligned valve which is not detected during the 100% leakage testing performed during manufacturing of the set.Additional investigations are being done to determine the root cause of this nature.The initial report was filed against the product ax1000, apex compounding system.The investigation has determined that the misaligned valve of product 2112550, apex transfer set, is the most probable cause of this incident.Medwatch (b)(4) has been filed for the transfer set.If additional pertinent information becomes available a follow-up report will be filed.

Event Description

As per user facility: when initially priming port 7 (potassium chloride) occlusions were received.Customer was able to get past the occlusions after troubleshooting and power-cycling the pump.Upon priming port 19 (adult mvi), and priming very slow, it was noticed the port 7 micro side looked like it was being primed.A yellow tint was noticed in line 7.There were no crimps or kinks seen in the transfer set lines that would cause a possible back up of solution.It was indicated port 7 micro had potassium chloride coming down the line as if it were being primed and a tint of yellow mixed in.This would indicate port 7 valve may have been compromised causing the potassium chloride to come down the line and the mvi from port 19 (while being primed) to enter the compromised valve 7 and mix with the potassium chloride causing a yellow tint in the solution.It was immediately advised to replace the transfer set and scrap the bag.No patient involvement.

• Brand Name: APEX¿
• Type of Device: COMPOUNDER
• Manufacturer (Section D): B. BRAUN MEDICAL INC; 1601 wallace drive, suite 150; carrollton TX 75006 6690
• MDR Report Key: 7236644
• MDR Text Key: 98896549
• Report Number: 1641965-2018-00001
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 04046955048502
• UDI-Public: (01)04046955048502
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AX1000
• Device Catalogue Number: AX1000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1