Sorin Centrifugal Pump 5 (CP5)

• • Terminated Z-0787-2022 FDA Class III ·initiated 17 Dec 2021

  One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.

• • Terminated Z-0401-2018 FDA Class II ·initiated 30 Oct 2017

  Possibility that the automatic line closure by the Electronic Remote-Controlled (ERC) clamp after detection of an air bubble could take longer than is intended by design in the CP5 system.

• • Terminated Z-0857-2014 FDA Class II ·initiated 4 Dec 2013

  Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump system due to reports of pump speed control knob failures resulting in no response.

• • Terminated Z-1329-2012 FDA Not yet classified ·initiated 23 Feb 2012

  The pump speed control knob is attached to the shaft of an encoder that is used to adjust the speed. Insufficient lubrication within the encoder increases friction over time making it more difficult to turn the pump speed control knob. Excessive friction causes premature wear of the encoder shaft which can result in a stuck shaft.

510(k) Number

K112225 ↗

FDA Product Code

DWA

Device Class

Class II

Regulation

21 CFR Part 870.4380

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Modification to Stockert S5 System

  Class II

  FDA 510(k) K062396 Active Cleared 28 Sep 2006

• Modification to: Stockert S5 System

  Class II

  FDA 510(k) K071318 Active Cleared 6 Jul 2007

• Sorin C5 System; 85/C5 Mast Roller Pump System 150(1X Rp 150 and Control Panel with Connecting Cables); S5/C5 Mast Rolle

  Class II

  FDA 510(k) K103762 Active Cleared 20 Jan 2011

• Air Purge Control System for S5 System Model 23-45-05

  Class II

  FDA 510(k) K091007 Active Cleared 2 Jul 2009

• Xtra

  Class II

  FDA 510(k) K131553 Active Cleared 21 Mar 2014

• Sorin Connect

  Class II

  FDA 510(k) K170460 Active Cleared 8 Jun 2017

See all devices from Sorin Group Deutschland GmbH →

• What is the Sorin Centrifugal Pump 5 (CP5) used for?

  The Sorin Centrifugal Pump 5 (CP5) is indicated for use exclusively with the Sorin Revolution® system for speed-controlled pumping through the cardiopulmonary bypass circuit, functioning as a control pump speed device during cardiopulmonary bypass procedures.

• How is the Sorin Centrifugal Pump 5 (CP5) supplied and what is its intended duration of use?

  The device is supplied as a drive unit and is intended for typical durations of six hours or less during cardiopulmonary bypass procedures.

• What regulatory pathway was used for the Sorin Centrifugal Pump 5 (CP5) and what is its classification?

  The Sorin Centrifugal Pump 5 (CP5) received FDA 510(k) clearance under K112225 with product code DWA and regulation number 870.4380, and is classified as a Class II device in the cardiovascular medical specialty.