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  

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.

• 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: 8995887
• MDR Text Key: 159823565
• Report Number: 2521402-2019-00008
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/11/2019

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

• Device Model Number: 710200L
• Device Catalogue Number: 710200L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/11/2019
• Distributor Facility Aware Date: 08/13/2019
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/11/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 09/11/2019 Patient Sequence Number: 1