Devices › Controller, temperature, cardiopulmonary bypass
Device brand name · Controller temperature cardiopulmonary bypass
Heater-Cooler System 3t: medical device reports filed with FDA
3,380 reports name it, 2015–2026. Manufacturer given most often on reports: Livanova Deutschland. Product code DWC.
- 3,380
- device reports naming the brand
- 0% of all MAUDE reports · about 305 a year
- 8
- reports, 12 months to August 2026
- 146 in the 12 months before
- 88%
- classified as malfunction
- 86.9% across the product code
- 3.5%
- classified as death, as reported
- 118 reports · not verified by FDA
FDA's MAUDE database holds 3,380 reports that name the brand "Heater-Cooler System 3t" (controller temperature cardiopulmonary bypass), received between June 2015 and April 2026; the manufacturer given most often on reports is Livanova Deutschland. Spellings of one product vary from report to report.
8 reports arrived in the 12 months to August 2026, down 95% from 146 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 (88%), injury (8%) and death (3.5%); 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 microbial contamination of device (48.1%), pumping problem (8.3%) and temperature problem (8%). The patient problems coded most often are no patient involvement, bacterial infection and death. 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
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
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 |
|---|---|---|---|
| Microbial contamination of device | 1,625 | 48.1% | 38.9% |
| Pumping problem | 281 | 8.3% | 4.5% |
| Temperature problem | 272 | 8% | 8.6% |
| Electrical shorting | 208 | 6.2% | 2.9% |
| Device displays incorrect message | 165 | 4.9% | 7.6% |
| Insufficient cooling | 127 | 3.8% | 4.1% |
| Fluid/blood leak | 87 | 2.6% | 2.3% |
| Insufficient heating | 71 | 2.1% | 4.3% |
| Electrical /electronic property probleman electrical or electronic problem | 49 | 1.4% | 1.4% |
| Pumping stopped | 37 | 1.1% | 1.2% |
| Other (for use when an appropriate device code cannot be identified) | 23 | 0.7% | 1% |
| Failure to pump | 21 | 0.6% | 0.6% |
| Unexpected shutdown | 20 | 0.6% | 0.3% |
| Infusion or flow problema problem with flow or infusion | 16 | 0.5% | 0.7% |
| Noise, audible | 14 | 0.4% | 0.6% |
| Thermal decomposition of device | 14 | 0.4% | 0.4% |
| Failure to power up | 11 | 0.3% | 0.5% |
| Insufficient device problem information | 11 | 0.3% | 0.9% |
| Loss of powerthe device lost power | 11 | 0.3% | 0.4% |
| Smoking | 10 | 0.3% | 0.6% |
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 | 763 | 22.6% |
| Bacterial infectiona bacterial infection | 349 | 10.3% |
| Deaththe patient died; cause not stated by this term | 49 | 1.4% |
| Fever | 13 | 0.4% |
| Endocarditis | 10 | 0.3% |
| Fatiguetiredness | 9 | 0.3% |
| Post operative wound infection | 9 | 0.3% |
| Weight changes | 7 | 0.2% |
| Alteration in body temperature | 2 | 0.1% |
| Injurya physical injury | 2 | 0.1% |
| Painpain, site not specified | 2 | 0.1% |
| Respiratory tract infectiona respiratory infection | 2 | 0.1% |
| Sweating | 2 | 0.1% |
| Anxietyanxiety | 1 | 0% |
| Aortic insufficiency | 1 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Heater-Cooler System 3t | Product code DWC | All MAUDE reports |
|---|---|---|---|
| Reports | 3,380 | 9,208 | 26,136,888 |
| Share of that pool | — | 36.7% | 0% |
| Classified as death, per 1,000 reports | 35 | 22 | 9 |
| Classified as injury | 8% | 6.8% | 36.2% |
| Classified as malfunction | 88% | 86.9% | 62.3% |
| Filed by the manufacturer | 97.3% | 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 |
|---|---|---|---|
| CardioQuip Modular Cooler Heater | 1,367 | 297 | 0.3% |
| Sorin Heater-Cooler System 3t | 553 | 0 | 2.2% |
| Dual Cooler/Heater | 358 | 0 | 0% |
| 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 Heater-Cooler System 3t reports
How many FDA reports name Heater-Cooler System 3t?
3,380 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 8 in the latest 12 months.
What kinds of events are reported?
malfunction (88%), injury (8%) and death (3.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
microbial contamination of device (48.1%), pumping problem (8.3%), temperature problem (8%), electrical shorting (6.2%) and device displays incorrect message (4.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (97.3%), distributor reports (2.7%) and voluntary reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Heater-Cooler System 3t 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.