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

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).

• Brand Name: FRESENIUS 2008T BLUESTAR BIGBAG DIALYSIS MACHINE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): FRESENIUS USA, INC.
• MDR Report Key: 10712167
• MDR Text Key: 212519664
• Report Number: MW5097350
• Device Sequence Number: 1
• Product Code: KDI
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 2008T
• 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