Controller, Temperature, Cardiopulmonary Bypass
FDA adverse event reports and recall history for controller, temperature, cardiopulmonary bypass (product code DWC), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 9,116
- Deaths
- 204
- Injuries
- 626
- Malfunctions
- 7,909
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2023-12-15Open, ClassifiedProcess control
CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
- 2023-12-15Open, ClassifiedProcess control
CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
- 2023-12-01Open, ClassifiedDevice Design
CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A
There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.
- 2023-12-01Open, ClassifiedDevice Design
CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A
There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.
- 2023-10-06Open, ClassifiedLabeling Change Control
3T Heater Cooler System, REF: 16-02-85
The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.
- 2021-10-06Open, ClassifiedError in labeling
CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
- 2021-10-06Open, ClassifiedError in labeling
CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
- 2021-10-06Open, ClassifiedError in labeling
CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
- 2021-10-06Open, ClassifiedError in labeling
CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
- 2018-10-03TerminatedDevice Design
Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator/Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper/hypothermia blanket under the patient to provide warming through conductive heat transfer.
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.
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