MAUDE Adverse Event Report: FRESENIUS AIR SEPARATOR

Model Number 2008T

Device Problems Device Operates Differently Than Expected (2913); Pressure Problem (3012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/13/2014

Event Type  Injury  

Event Description

I am technician in a dialysis unit at (b)(6).I am responsible for fixing and maintaining the fresenius 2008t dialysis machines.I want to report an issue with the machines and a part that is failing within the machine.We purchased (b)(6) of these machines and had them installed around on (b)(6) 2011 and (b)(6) more around on (b)(6) 2013.I have had many issues with a tmp (trans-membrane pressure) problem.The pressure in the machine keeps rising to a point where a pressure alarm goes off and the treatment stopped and needed to be adjusted (hit reset, or maybe put a new transducer protector on the level detector) in order to continue treatment.This happens for the entire 3 hour treatment.I have done trouble shooting scenarios and there is one part that keeps failing.This part is called the air separator part # 672390.I have had the fresenius technicians come out to replace several of these air separators when the machines were under manufacturer warranty and i also have ordered to many of these air separators to repair machines off of warranty.I recently had placed an order and the part was on back order.I had 3 machines in my office and had to wait 3 weeks to get the part to fix them.I only have a limited number of spare machines and every machine that was in need of repair had the same symptoms.There is clearly an on going issue with the manufacturing of this part and if i can't get the part because it is on back order from (b)(4) we might not be able to treat our pts.I contacted fresenius and their answer was "they are on back order." i asked what will happen if i can't dialyze pts because i don't have the part to fix the machines.They gave the same answer that they are on back order.Is this back order part going to fail once i put them in my machines and i have to go through the same situation again? i also feel we should be reimbursed for the prior purchases of this faulty part.Please help me keep my pts safe.

• Brand Name: AIR SEPARATOR
• Type of Device: AIR SEPARATOR
• Manufacturer (Section D): FRESENIUS
• MDR Report Key: 3690849
• MDR Text Key: 4254427
• Report Number: MW5035034
• Device Sequence Number: 1
• Product Code: LKN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2008T
• Device Catalogue Number: 672 390
• Patient Sequence Number: 1
• Patient Outcome(s): Disability