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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  
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.
 
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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
Manufacturer (Section G)
B. BRAUN AVITUM AG - MELSUNGEN
schwarzenberger weg 73-79
melsungen, D-342 12
GM D-34212
Manufacturer Contact
jonathan severino
824 12th avenue
bethlehem, PA 18018-0027
4842408332
MDR Report Key8995914
MDR Text Key161737885
Report Number3002879653-2019-00008
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083460
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
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 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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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