Fresenius 2008T Hemodialysis Machine with Bibag System

• • Terminated Z-0829-2018 FDA Class II ·initiated 5 Oct 2017

  While reviewing documentation for the next software release of the 2008T, an R&D technician identified that setting the UF goal to '0' introduces a discrepancy between the UF rate displayed and the actual UF pump rate. The software anomaly is also applicable to the 2008T Machines that contained the 2.63 Bug Fix per DCAF 17-088. 2008T Upgrade kits that contained the 2.63 Bug Fix are also affected. Additionally, SW version 2.64 (in design freeze) is also impacted by this anomaly.

• • Terminated Z-1325-2016 FDA Class II ·initiated 10 Mar 2016

  Added Warning Statement: Fresenius 2008 Series Hemodialysis Machines False Blood Leak Alarm When Dialyzing Patients Treated with Hydroxocobalamin (or any form of Vitamin B-12)

• • Terminated Z-1550-2015 FDA Class II ·initiated 20 Feb 2015

  The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.

• • Terminated Z-1015-2015 FDA Class II ·initiated 16 Dec 2014

  Unqualified power assemblies shipped to customers.

• • Terminated Z-1618-2014 FDA Class II ·initiated 25 Apr 2014

  2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump

510(k) Number

K121341 ↗

FDA Product Code

KDI

Device Class

Class II

Regulation

21 CFR Part 876.5860

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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