MAUDE Adverse Event Report: B. BRAUN AVITUM AG - MELSUNGEN DIALOG+® ; DIALYZER, HIGH PERMEABILIT

Model Number 710200L

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Respiratory Distress (2045)

Event Date 08/06/2019

Event Type  Injury  

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number: (b)(4).The investigation into this reported event is ongoing.A follow-up report will be submitted when the results of the investigation are available.

Event Description

As reported by user facility: we saw a half inch long air bubble in the arterial line during a dialysis treatment.Here is the event details: tx started at 0900 with a tunneled catheter (2nd hd treatment).Staff said the catheter accessed normally and worked well with a bfr of 250 the first 10 minutes, and said there were no alarms.Staff noticed an apnea alarm on the cardiac monitor, cleared it, and breathing went back to normal.Had another period of apnea right after this and icu nurse came in room and noted patient was not breathing and called a code.At this point staff said she saw a 1/2 inch long bubble of air in the arterial line at the patient connection area (located within the tubing, not the catheter).She placed the lines in recirc and the air got circulated out in the venous chamber.While in recirc.The blood remained in recirc while they coded the patient, and was not able to return blood due to the time being over 30 minutes.Staff pulled the machine, called biomed to check the machine out, and also double bagged the tubing (filled with unreturned blood).Nephrologist thought a mucous plug likely that caused the respiratory arrest.Patient was on the machine for approx 9 minutes before code was called.Successful at coding pt during this incident.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).The described event occurred (b)(6) 2019.The user facility stated the patient coded multiple times before this event, including an event that happened in (b)(6), and that the patient expired (b)(6) 2019 due to unrelated reasons.The nephrologist in charge thought it likely that a mucous plug had caused the respiratory arrest.It was the third time the patient had a respiratory arrest in the past few weeks.He thinks that the respiratory arrest caused an excessively high arterial pressure that perhaps pulled air from the connection or the area of the tego adapter into the arterial tubing going to the machine.The nurse said that there were no alarms up until the code event and she was trying to place the blood line into recirculation.The arterial pressure were in the mid 100's mmhg and the venous pressures 100-130 mmhg during the first 10 minutes of the therapy.The blood line used during this therapy was not manufactured by b.Braun avitum ag.The data record of the dialog+ machine of the described event was not available for investigation, but the dialysis machine was technically inspected by the customer's technician.There was no malfunction.The device operated as intended and was returned into service.If there is a leakage of the blood line system before the blood pump, in the area of negative pressure before the blood pump, air might leak into the arterial line.The air is transported to the venous bubble catcher where the air is collected.Air passing through the venous bubble catcher is detected by the safety air detector (sad) of the dialog+ machine.As a consequence, the dialysis machine alarms and switches into patient-safe mode.The blood pump stops and the venous tube clamp (sakv) closes preventing air from being infused into the patient.In the current case air was observed in the arterial line.It had not yet advanced into the venous bubble catcher and did not reach the sad and therefore, no alarm was triggered.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: DIALOG+®
• Type of Device: DIALYZER, HIGH PERMEABILIT
• Manufacturer (Section D): B. BRAUN AVITUM AG - MELSUNGEN; schwarzenberger weg 73-79; melsungen, D-342 12; GM D-34212
• MDR Report Key: 8995914
• MDR Text Key: 161737885
• Report Number: 3002879653-2019-00008
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 04046963686345
• UDI-Public: (01)04046963686345
• Combination Product (y/n): N
• PMA/PMN Number: K083460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 710200L
• Device Catalogue Number: 710200L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 82 YR