# K102147: Cardioquip Modular Cooler-Heater Model MCH-1000

- Pathway: 510(k) (Traditional)
- Applicant: Cardioquip Llp
- Decided: Nov 19, 2010 after 112 days
- Product code: DWC (Controller, Temperature, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4250
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Recalls of this device
- Oct 24, 2023 · Class II · Z-0565-2024: There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
- Oct 24, 2023 · Class II · Z-0566-2024: There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
- Oct 19, 2023 · Class II · Z-0438-2024: There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.
- Oct 19, 2023 · Class II · Z-0439-2024: There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.
- Jun 24, 2021 · Class II · Z-0069-2022: There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of heater-cooler devices which could result in contaminated water potentially aerosolized into
- May 12, 2021 · Class II · Z-0036-2022: Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
- May 12, 2021 · Class II · Z-0035-2022: Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
- May 12, 2021 · Class II · Z-0037-2022: Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
- May 12, 2021 · Class II · Z-0038-2022: Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.

## Indications for use
The CardioQuip Modular Cooler-Heater (MCH) is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.

Source page: https://510kreport.com/device/K102147
Methodology: https://510kreport.com/methodology