Device product

Fresenius 2008K Series : Hemodialysis System

Z-1027-2017

December 21, 2016

Class II

Product summary

Firm: Fresenius Medical Care Renal Therapies Group, LLC
Event: Event 76037
Status: Terminated
Classification: Class II
Quantity: 78481 (US) 2734 units (OUS)
Official record key: device-enforcement:Z-1027-2017

Official wording

Reason: When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine

Code information: All serial numbers

Distribution pattern: Nationwide Foreign: Canada, Mexico, Jamaica, Germany, Guam

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine