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U.S. Department of Health and Human Services

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

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B. BRAUN AVITUM AG - MELSUNGEN DIALOG+®  DIALYZER, HIGH PERMEABILIT Back to Search Results
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.
 
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Brand NameDIALOG+® 
Type of DeviceDIALYZER, HIGH PERMEABILIT
Manufacturer (Section D)
B. BRAUN AVITUM AG - MELSUNGEN
schwarzenberger weg 73-79
melsungen, D-342 12
GM D-34212
MDR Report Key8995887
MDR Text Key159823565
Report Number2521402-2019-00008
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received09/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number710200L
Device Catalogue Number710200L
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/11/2019
Distributor Facility Aware Date08/13/2019
Event Location Outpatient Treatment Facility
Date Report to Manufacturer09/11/2019
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
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