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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS USA, INC. FRESENIUS 2008T BLUESTAR BIGBAG DIALYSIS MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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FRESENIUS USA, INC. FRESENIUS 2008T BLUESTAR BIGBAG DIALYSIS MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 2008T
Device Problems Product Quality Problem (1506); Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
The latest generation of fresenius 2008t dialysis machines are horrible. The circuit boards and their connections are cheap and flimsy. I have worked on their machines for over a decade and have never seen a batch of machines that are so glitchy and defective. I have probably replaced 20 or 30 circuit boards in a 4 year window. Things have never been this bad. These machines sometimes, out of the box have errors or alarms. I'm having more problems at 2000 hrs than the previous k machine would have at 10,000 hours or more. The bluestar is even worse. They are either poorly designed or cheaply made. It is wearing out treatment and biomedical staff. Someone needs to hold their feet to the fire. This is a very arrogant company full of employees who are out of touch with what goes on in the field. They don't see or deal with these burdens, so they go around acting like these machines are the greatest invention since the wheel. The product complaint channel in the company won't get back with us on complaints. They're either overwhelmed or don't care. I've heard the field technicians are overwhelmed. I have a bluestar machine in a hospital with less than 1000 hrs, and it's giving me a bibag related alarm and after replacing 4 or 5 parts, i'm told the error still reemerges on occasion. It's like they have made a machine that simply does not want to be fixed. Fda safety report id# (b)(4).
 
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Brand NameFRESENIUS 2008T BLUESTAR BIGBAG DIALYSIS MACHINE
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
FRESENIUS USA, INC.
MDR Report Key10712167
MDR Text Key212519664
Report NumberMW5097350
Device Sequence Number1
Product Code KDI
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 10/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2008T
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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