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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS USA, INC. 2008® SERIES HEMODIALYSIS MACHINES DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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FRESENIUS USA, INC. 2008® SERIES HEMODIALYSIS MACHINES DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 190858
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 02/23/2022
Event Type  malfunction  
Event Description
When the patient was connected to the hemodialysis machine the machine was alarming high conductivity, not reading transmembrane pressure (tmp), and said low flow error. There was an attempt to reset the machine, but due to high pressures that were not reading and no tmp reading the patient's venous site on the left av fistula infiltrated.
 
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Brand Name2008® SERIES HEMODIALYSIS MACHINES
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
FRESENIUS USA, INC.
920 winter street
waltham MA 02451
MDR Report Key13794847
MDR Text Key287332471
Report Number13794847
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 Risk Manager
Type of Report Initial
Report Date 03/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number190858
Device Lot Number2008T
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/03/2022
Event Location Hospital
Date Report to Manufacturer03/17/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Type of Device Usage Unkown

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