Hemotherm Model 400CE Cooler/Heater System

• • Terminated Z-2092-2021 FDA Class II ·initiated 17 Jun 2021

  There is a potential risk of device contamination and patient infection associated with the device because of the potential for organisms (including Nontuberculous mycobacteria NTM) to grow in the water systems of any heater-cooler device, and contaminated water from any heater-cooler device has the potential to aerosolize into the operating room during surgery which could lead to patient infection.

• • Terminated Z-0825-2019 FDA Class II ·initiated 19 Dec 2018

  Evidence supports that when customers performed a fuse replacement as part of a March 2017 field action, the fuse clips became stretched and were no longer mechanically tight with the fuse, creating a host spot that led to discoloration on the board due to overheating and shut down of the device.

• • Terminated Z-0063-2019 FDA Class II ·initiated 4 Sep 2018

  Potential for membrane (control panel) switch errors leading to an inability of the device to change control settings or an unintended change to control settings.

• • Terminated Z-0629-2018 FDA Class II ·initiated 27 Nov 2017

  Due to FDA's safety communication relating to nontuberculous mycobacteria (NTM) infections related to heater/cooler devices, an updated Instructions For Use includes a more robust cleaning & disinfection procedure.

• • Terminated Z-1825-2017 FDA Class II ·initiated 9 Mar 2017

  Improperly rated fuses were used in the manufacture of the device.

• • Terminated Z-0654-2017 FDA Class II ·initiated 7 Nov 2016 ·on shared 510(k) K122813

  The device may not maintain water flow or temperature control.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K122813 ↗

FDA Product Code

DWC

Device Class

Class II

Regulation

21 CFR Part 870.4250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Cincinnati Sub-Zero Products, Inc. →

• What is the Hemotherm Model 400CE Cooler/Heater System used for?

  The Hemotherm Model 400CE Cooler/Heater System is a controller designed to provide precise blood temperature control during cardiopulmonary bypass procedures, such as cardiovascular surgeries and related procedures, by managing the temperature of blood circulated through the bypass circuit.

• Is the Hemotherm Model 400CE Cooler/Heater System intended for single-use or reuse?

  The Hemotherm Model 400CE Cooler/Heater System is supplied as a reusable system for use in clinical settings such as operating rooms. It requires cleaning and maintenance between uses and is not intended for single-use disposal, ensuring it can be safely reprocessed for multiple procedures.

• What regulatory pathway was used for the Hemotherm Model 400CE Cooler/Heater System?

  The Hemotherm Model 400CE Cooler/Heater System operates under FDA 510(k) clearance (K122813) as a Class II medical device with product code DWC, regulated under 870.4250 for temperature controllers in cardiopulmonary bypass applications, based on a determination of substantial equivalence to a predicate device.