Devices › Controller, temperature, cardiopulmonary bypass
Device brand name · Cooling & heating system
Dual Cooler/Heater: medical device reports filed with FDA
358 reports name it, 2010–2015. Manufacturer given most often on reports: Terumo Cardiovascular Systems. Product code DWC.
- 358
- device reports naming the brand
- 0% of all MAUDE reports · about 22 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 100%
- classified as malfunction
- 86.9% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
358 medical device reports received by FDA name the brand "Dual Cooler/Heater" (cooling & heating system); the manufacturer given most often on reports is Terumo Cardiovascular Systems; received from June 2010 to April 2015. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (100%); across all controller, temperature, cardiopulmonary bypass reports (product code DWC) death is recorded in 2.2% and malfunction in 86.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are temperature problem (16.8%), device operates differently than expected (14%) and insufficient heating (12.3%). The patient problems coded most often are no patient involvement and not applicable. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
No report naming Dual Cooler/Heater was received in the five years to August 2026; the latest was received in April 2015.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 9,208 reports carrying product code DWC. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Temperature problem | 60 | 16.8% | 8.6% |
| Device operates differently than expectedthe device behaved unexpectedly | 50 | 14% | 4.5% |
| Insufficient heating | 44 | 12.3% | 4.3% |
| Leak/splashthe device leaked | 43 | 12% | 1.6% |
| Component missing | 17 | 4.7% | 0.2% |
| Overheating of device | 13 | 3.6% | 0.7% |
| Fracturea broken bone | 11 | 3.1% | 0.2% |
| Insufficient cooling | 10 | 2.8% | 4.1% |
| Torn material | 9 | 2.5% | 0.1% |
| Breakthe device broke | 8 | 2.2% | 0.3% |
| Device inoperablethe device could not be used | 8 | 2.2% | 0.7% |
| Ambient noise problem | 7 | 2% | 0.4% |
| Improper flow or infusion | 7 | 2% | 0.4% |
| Failure to pump | 5 | 1.4% | 0.6% |
| Difficult to open or close | 4 | 1.1% | 0.1% |
| Fluid/blood leak | 4 | 1.1% | 2.3% |
| Failure to power up | 3 | 0.8% | 0.5% |
| Grounding malfunction | 3 | 0.8% | 0.1% |
| Crackthe device cracked | 2 | 0.6% | 0.1% |
| Device alarm system | 2 | 0.6% | 0.7% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| No patient involvement | 188 | 52.5% |
| Not applicable | 19 | 5.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Dual Cooler/Heater | Product code DWC | All MAUDE reports |
|---|---|---|---|
| Reports | 358 | 9,208 | 26,136,888 |
| Share of that pool | — | 3.9% | 0% |
| Classified as death, per 1,000 reports | 0 | 22 | 9 |
| Classified as injury | 0% | 6.8% | 36.2% |
| Classified as malfunction | 100% | 86.9% | 62.3% |
| Filed by the manufacturer | 100% | 95.4% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code DWC
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Heater-Cooler System 3t | 3,380 | 8 | 3.5% |
| CardioQuip Modular Cooler Heater | 1,367 | 297 | 0.3% |
| Sorin Heater-Cooler System 3t | 553 | 0 | 2.2% |
| Hx2 Temperature Management System | 293 | 0 | 0.7% |
| Maquet Hcu30 Device | 290 | 0 | 1% |
| S5 Gas Blender System | 383 | 0 | 0% |
| Terumo Advanced Perfusion System One | 461 | 0 | 0% |
| Centrifugal Pump System With Tubing Clamp | 167 | 0 | 0.6% |
| S5 Roller Pump | 1,178 | 0 | 0.6% |
| Terumo Advanced Perfusion System 1 | 5,074 | 0 | 0.2% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Dual Cooler/Heater reports
How many FDA reports name Dual Cooler/Heater?
358 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
temperature problem (16.8%), device operates differently than expected (14%), insufficient heating (12.3%), leak/splash (12%) and component missing (4.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Dual Cooler/Heater was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.