Fresenius 2008T Hemodialysis Machine

• • 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-1693-2013 FDA Class II ·initiated 24 May 2013

  Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Propylene Dine Monomer (M-class) rubber)

510(k) Number

K120505 ↗

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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  Class II

  FDA 510(k) K070177 Active Cleared 29 Mar 2007

• Crit-Line Clip (Clic) Blood Chamber

  Class II

  FDA 510(k) K152953 Active Cleared 5 Nov 2015

• Optiflux dialyzer Open recall

  Class II

  FDA 510(k) K162488 Active Cleared 6 Apr 2017

• Fresenius Art Hemoadsorption System

  Unclassified

  FDA 510(k) K050273 Active Cleared 8 Jun 2005

• Frsenius Pd Iqcard Cycler

  Class II

  FDA 510(k) K002892 Active Cleared 5 Apr 2001

• Fresenius on Line Clearance Monitor with the Addition of Access Flow Determination

  Class II

  FDA 510(k) K991520 Active Cleared 30 Jul 1999

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