MAUDE Adverse Event Report: FRESENIUS USA, INC. FRESENIUS HEMODIALYSIS MACHINE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 2008K2

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Scar Tissue (2060)

Event Date 12/27/2017

Event Type  Injury  

Event Description

Patient called to report an adverse event she experiences which she believes is tied to the hemodialysis machine she uses.Patient stated she has been using the fresenius machine for dialysis 3 times a week overnight for the past 5 years and experiences severe itching from head to toe all night long while receiving dialysis.Patient stated the itching is so severe it has caused scarring on her arm and believes this is a reaction to the machine.Patient stated she became aware of information available on the fda website of a device issue with this model number machine resulting in recalls or machines being discontinued.Patient stated she is concerned that the machine she is using could have an issue with the silicone tubing in the hydraulics of the machine and that dialysate could be getting into contact with the blood causing the itching reaction.

• Brand Name: FRESENIUS HEMODIALYSIS MACHINE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): FRESENIUS USA, INC.
• MDR Report Key: 15970410
• MDR Text Key: 305489036
• Report Number: MW5113748
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• 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: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 2008K2
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Female