Controller, temperature, cardiopulmonary bypass: medical device reports filed with FDA

9,208 reports carry this product code, 1996–2026; 11 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

9,208
reports with this product code: 0% of all MAUDE reports; 650
reports, 12 months to August 2026: 638 in the 12 months before; 86.9%
classified as malfunction: 62.3% across all reports; 2.2%
classified as death, as reported: 0.9% across all reports

Product code DWC is FDA's classification for "Controller, temperature, cardiopulmonary bypass" (cardiovascular panel), a class 2 device. 9,208 medical device reports carry this product code, 0% of the MAUDE database, from April 1996 to August 2026.

650 reports arrived in the 12 months to August 2026, close to the 638 of 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 (86.9%), injury (6.8%) and death (2.2%). 11 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Heater-Cooler System 3t	3,371	8	3.5%	88%
CardioQuip Modular Cooler Heater	1,366	297	0.3%	99.3%
Sorin Heater-Cooler System 3t	552	0	2.2%	30.4%
Dual Cooler/Heater	345	0	0%	100%
Hx2 Temperature Management System	293	0	0.7%	98.3%
Maquet Hcu30 Device	277	0	1%	78.6%
S5 Gas Blender System	4	0	0%	90.6%
Terumo Advanced Perfusion System One	3	0	0%	98.3%
Centrifugal Pump System With Tubing Clamp	1	0	0.6%	95.2%
S5 Roller Pump	1	0	0.6%	73.2%
Terumo Advanced Perfusion System 1	1	0	0.2%	99.2%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Livanova Deutschland	4,132	44.9%
Terumo Cardiovascular Systems	1,536	16.7%
Cardioquip	1,455	15.8%
Maquet Cardiopulmonary	769	8.4%
Sorin Group Deutschland	594	6.5%
Terumo Cardiovascular System	253	2.7%
Livanova USA	18	0.2%
Maquet Critical Care	12	0.1%
Maquet	4	0%
Terumo	3	0%
Abbott Manufacturing	1	0%
Maquet Cardiovascular	1	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death2.2%204

Injury6.8%627

Malfunction86.9%8,000

Other0.9%79

Not given3.2%298

Who filed

Manufacturer report95.4%8,787

Voluntary report1.9%176

User facility report0%0

Distributor report1.6%144

Not given1.1%101

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Microbial contamination of device	3,585	38.9%
Temperature problem	791	8.6%
Device displays incorrect message	698	7.6%
Pumping problem	417	4.5%
Device operates differently than expectedthe device behaved unexpectedly	415	4.5%
Insufficient heating	396	4.3%
Insufficient cooling	376	4.1%
Electrical shorting	270	2.9%
Fluid/blood leak	208	2.3%
Leak/splashthe device leaked	145	1.6%
Electrical /electronic property probleman electrical or electronic problem	128	1.4%
Pumping stopped	112	1.2%
Other (for use when an appropriate device code cannot be identified)	95	1%
Insufficient device problem information	87	0.9%
No flow	84	0.9%
Device stops intermittentlythe device stopped now and then	66	0.7%
Device alarm system	64	0.7%
Infusion or flow problema problem with flow or infusion	62	0.7%
Overheating of device	62	0.7%
Device inoperablethe device could not be used	61	0.7%

Questions about controller, temperature, cardiopulmonary bypass reports

What is product code DWC?

FDA's classification code for "Controller, temperature, cardiopulmonary bypass", class 2, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.

How many reports carry this code?

9,208 reports through August 2026, 650 of them in the latest 12 months.

Which brands appear most often?

Heater-Cooler System 3t (3,371), CardioQuip Modular Cooler Heater (1,366), Sorin Heater-Cooler System 3t (552), Dual Cooler/Heater (345) and Hx2 Temperature Management System (293). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.