HEATING COOLING SYSTEM
This device is manufactured by TERUMO CARDIOVASCULAR SYSTEMS CORP, TERUMO CARDIOVASCULAR SYSTEMS CORPORATION.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2019 | Sparking | 1 | Device |
| 2019 | Pumping Problem | 1 | Device |
| 2019 | Output Problem | 2 | Device |
| 2019 | Microbial Contamination of Device | 6 | Device |
| 2019 | Intermittent Loss of Power | 1 | Device |
| 2019 | Insufficient Heating | 1 | Device |
| 2019 | Insufficient Flow or Under Infusion | 1 | Device |
| 2019 | Insufficient Cooling | 2 | Device |
| 2019 | Fluid/Blood Leak | 1 | Device |
| 2019 | Failure to Power Up | 1 | Device |
| 2018 | Unexpected Shutdown | 1 | Device |
| 2018 | Pumping Stopped | 1 | Device |
| 2018 | Power Problem | 1 | Device |
| 2018 | Overheating of Device | 1 | Device |
| 2018 | No Flow | 1 | Device |
| 2018 | Microbial Contamination of Device | 1 | Device |
| 2018 | Mechanical Problem | 1 | Device |
| 2018 | Material Fragmentation | 1 | Device |
| 2018 | Leak/Splash | 1 | Device |
| 2018 | Insufficient Heating | 4 | Device |
| 2018 | Insufficient Cooling | 6 | Device |
| 2018 | Infusion or Flow Problem | 3 | Device |
| 2018 | Improper Flow or Infusion | 2 | Device |
| 2018 | Fluid/Blood Leak | 3 | Device |
| 2018 | Electrical Power Problem | 2 | Device |
| 2018 | Device Sensing Problem | 1 | Device |
| 2018 | Device Operates Differently Than Expected | 6 | Device |
| 2018 | Device Displays Incorrect Message | 2 | Device |
| 2018 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2018 | Component Missing | 1 | Device |
| 2018 | Complete Blockage | 1 | Device |
| 2017 | Sticking | 1 | Device |
| 2017 | Pumping Stopped | 1 | Device |
| 2017 | Pumping Problem | 8 | Device |
| 2017 | Overheating of Device | 1 | Device |
| 2017 | Noise, Audible | 2 | Device |
| 2017 | No Flow | 2 | Device |
| 2017 | Microbial Contamination of Device | 3 | Device |
| 2017 | Mechanical Problem | 1 | Device |
| 2017 | Leak/Splash | 4 | Device |
| 2017 | Insufficient Heating | 4 | Device |
| 2017 | Insufficient Cooling | 4 | Device |
| 2017 | Infusion or Flow Problem | 3 | Device |
| 2017 | Incorrect Measurement | 2 | Device |
| 2017 | Improper Flow or Infusion | 1 | Device |
| 2017 | Fracture | 2 | Device |
| 2017 | Fluid/Blood Leak | 9 | Device |
| 2017 | Device Reprocessing Problem | 2 | Device |
| 2017 | Device Operates Differently Than Expected | 15 | Device |
| 2017 | Device Inoperable | 4 | Device |
| 2017 | Device Displays Incorrect Message | 4 | Device |
| 2017 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2017 | Device Contamination With Biological Material | 1 | Device |
| 2017 | Crack | 1 | Device |
| 2016 | Use of Device Problem | 1 | Device |
| 2016 | Temperature Problem | 6 | Device |
| 2016 | Pumping Problem | 1 | Device |
| 2016 | Power Problem | 1 | Device |
| 2016 | No Flow | 4 | Device |
| 2016 | Mechanical Problem | 3 | Device |
| 2016 | Loose or Intermittent Connection | 1 | Device |
| 2016 | Insufficient Heating | 4 | Device |
| 2016 | Insufficient Cooling | 2 | Device |
| 2016 | Infusion or Flow Problem | 1 | Device |
| 2016 | Improper Alarm | 1 | Device |
| 2016 | Fluid/Blood Leak | 7 | Device |
| 2016 | Failure to Prime | 1 | Device |
| 2016 | Electrical /Electronic Property Problem | 1 | Device |
| 2016 | Device Operates Differently Than Expected | 3 | Device |
| 2016 | Device Inoperable | 1 | Device |
| 2016 | Device Displays Incorrect Message | 1 | Device |
| 2016 | Device Alarm System | 1 | Device |
| 2015 | Restricted Flow rate | 1 | Device |
| 2015 | Pumping Problem | 1 | Device |
| 2015 | Noise, Audible | 1 | Device |
| 2015 | Leak/Splash | 1 | Device |
| 2015 | Insufficient Heating | 1 | Device |
| 2015 | Insufficient Cooling | 1 | Device |
| 2015 | Improper Flow or Infusion | 1 | Device |
| 2015 | Fluid/Blood Leak | 3 | Device |
| 2015 | Device Reprocessing Problem | 1 | Device |
| 2015 | Device Operates Differently Than Expected | 2 | Device |
| 2015 | Device Displays Incorrect Message | 2 | Device |
| 2015 | Connection Problem | 1 | Device |
| 2014 | Restricted Flow rate | 1 | Device |
| 2014 | Pumping Problem | 2 | Device |
| 2014 | Pressure Problem | 2 | Device |
| 2014 | Occlusion Within Device | 1 | Device |
| 2014 | Noise, Audible | 3 | Device |
| 2014 | No Flow | 2 | Device |
| 2014 | Leak/Splash | 8 | Device |
| 2014 | Insufficient Heating | 3 | Device |
| 2014 | Insufficient Cooling | 5 | Device |
| 2014 | Infusion or Flow Problem | 1 | Device |
| 2014 | Incorrect Measurement | 1 | Device |
| 2014 | Failure to Shut Off | 2 | Device |
| 2014 | Failure to Sense | 1 | Device |
| 2014 | Failure to Prime | 1 | Device |
| 2014 | Failure to Cycle | 1 | Device |
| 2014 | Device Stops Intermittently | 1 | Device |
| 2014 | Device Reprocessing Problem | 1 | Device |
| 2014 | Device Operates Differently Than Expected | 18 | Device |
| 2014 | Device Inoperable | 1 | Device |
| 2014 | Device Displays Incorrect Message | 5 | Device |
| 2014 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2014 | Device Alarm System | 1 | Device |
| 2014 | Connection Problem | 1 | Device |
| 2014 | Complete Blockage | 1 | Device |
| 2014 | Collapse | 1 | Device |
| 2014 | Circuit Failure | 2 | Device |
| 2013 | Temperature Problem | 2 | Device |
| 2013 | Partial Blockage | 1 | Device |
| 2013 | Failure to Power Up | 1 | Device |
| 2013 | Device Stops Intermittently | 1 | Device |
| 2013 | Device Operates Differently Than Expected | 4 | Device |