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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B.BRAUN AVITUM AG DIALOG+ EVOLUTION HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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B.BRAUN AVITUM AG DIALOG+ EVOLUTION HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 710200K
Device Problems Loose or Intermittent Connection (1371); Failure to Power Up (1476)
Patient Problem Insufficient Information (4580)
Event Date 02/22/2022
Event Type  malfunction  
Event Description
Dialysis staff brought dialysis ro and machine to the icu and set up in patient's room for a dialysis run. They left the room and unit when the green man was on the machine, and the night nurse was coming in to start the run. When the night nurse arrived to run the patient, the machine was off and would not turn on. The room nurse said it was running and then made a noise and shut off. Two dialysis nurses tried to troubleshoot and noticed that one of the prongs of the outlet to the machine was loose, when they touched it, it literally fell off.
 
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Brand NameDIALOG+ EVOLUTION HEMODIALYSIS SYSTEM
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
B.BRAUN AVITUM AG
824 12th ave
bethlehem PA 18018
MDR Report Key13885423
MDR Text Key287815812
Report Number13885423
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/16/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number710200K
Device Catalogue Number710200K
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/16/2022
Event Location Hospital
Date Report to Manufacturer03/24/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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