Devices › Controller, temperature, cardiopulmonary bypass
Device brand name · Cooling & heating system
Hx2 Temperature Management System: medical device reports filed with FDA
293 reports name it, 2010–2016. Manufacturer given most often on reports: Terumo Cardiovascular Systems. Product code DWC.
- 293
- device reports naming the brand
- 0% of all MAUDE reports · about 18 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 98.3%
- classified as malfunction
- 86.9% across the product code
- 0.7%
- classified as death, as reported
- 2 reports · not verified by FDA
293 medical device reports received by FDA name the brand "Hx2 Temperature Management System" (cooling & heating system); the manufacturer given most often on reports is Terumo Cardiovascular Systems; received from March 2010 to October 2016. 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 (98.3%), death (0.7%) and injury (0.7%); 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 device displays incorrect message (53.9%), device operates differently than expected (12.3%) and insufficient heating (12.3%). The patient problems coded most often are no patient involvement, not applicable and abscess. 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 Hx2 Temperature Management System was received in the five years to August 2026; the latest was received in October 2016.
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 |
|---|---|---|---|
| Device displays incorrect message | 158 | 53.9% | 7.6% |
| Device operates differently than expectedthe device behaved unexpectedly | 36 | 12.3% | 4.5% |
| Insufficient heating | 36 | 12.3% | 4.3% |
| Temperature problem | 13 | 4.4% | 8.6% |
| Leak/splashthe device leaked | 9 | 3.1% | 1.6% |
| Device alarm system | 7 | 2.4% | 0.7% |
| Breakthe device broke | 6 | 2% | 0.3% |
| Insufficient cooling | 6 | 2% | 4.1% |
| Fracturea broken bone | 5 | 1.7% | 0.2% |
| Material discolored | 5 | 1.7% | 0.1% |
| Material distortion | 5 | 1.7% | 0.1% |
| Insufficient device problem information | 4 | 1.4% | 0.9% |
| Ambient noise problem | 3 | 1% | 0.4% |
| Device inoperablethe device could not be used | 3 | 1% | 0.7% |
| Device reprocessing problem | 3 | 1% | 0.1% |
| Device stops intermittentlythe device stopped now and then | 3 | 1% | 0.7% |
| Fluid/blood leak | 3 | 1% | 2.3% |
| Impedance problem | 3 | 1% | 0.1% |
| Loose or intermittent connection | 3 | 1% | 0.1% |
| Low audible alarm | 3 | 1% | 0.1% |
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 | 76 | 25.9% |
| Not applicable | 5 | 1.7% |
| Abscessa collection of pus | 3 | 1% |
| Deaththe patient died; cause not stated by this term | 2 | 0.7% |
| Bacterial infectiona bacterial infection | 1 | 0.3% |
| Pseudoaneurysm | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Hx2 Temperature Management System | Product code DWC | All MAUDE reports |
|---|---|---|---|
| Reports | 293 | 9,208 | 26,136,888 |
| Share of that pool | — | 3.2% | 0% |
| Classified as death, per 1,000 reports | 7 | 22 | 9 |
| Classified as injury | 0.7% | 6.8% | 36.2% |
| Classified as malfunction | 98.3% | 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% |
| Dual Cooler/Heater | 358 | 0 | 0% |
| 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 Hx2 Temperature Management System reports
How many FDA reports name Hx2 Temperature Management System?
293 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 (98.3%), death (0.7%) and injury (0.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device displays incorrect message (53.9%), device operates differently than expected (12.3%), insufficient heating (12.3%), temperature problem (4.4%) and leak/splash (3.1%). 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 Hx2 Temperature Management System 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.