Fresenius Dialysate Systems (2016-12-21)

Starting date:

December 21, 2016

Posting date:

January 18, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-61828

• Reason
• Affected products

Affected Products

1. Fresenius 2008K Dialysate Delivery System
2. Fresenius 2008K2 Dialysate Delivery System
3. Fresenius 2008K2 Fifth Module Dialysate Delivery System
4. K@Home
5. Fresenius 2008T Hemodialysis System
6. Fresenius 2008K2@Home
7. Fresenius 2008T Hemodialysis System CDX
8. 2008T Hemodialysis System CDX - Refurbished
9. 2008K@Home - Refurbished
10. Fresenius 2008K2 Dialysate Delivery System

Reason

The purpose of this recall is to inform users of the 2008 series hemodialysis machines of a software issue pertaining to the ultrafiltration (UF) rate during treatment. It was discovered that when the UF rate, goal or time is adjusted using the "up" and "down" arrow keys of the hemodialysis machine and the change is cancelled using the "escape" key without pressing the "confirm" key first, the "cancelled" UF rate is actually being executed rather than the rate displayed on the machine.

Affected products