Console, heart-lung machine, cardiopulmonary bypass: medical device reports filed with FDA

17,404 reports carry this product code, 1992–2026; 27 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.

17,404
reports with this product code: 0.1% of all MAUDE reports; 1,149
reports, 12 months to August 2026: 948 in the 12 months before; 90.5%
classified as malfunction: 62.3% across all reports; 1.5%
classified as death, as reported: 0.9% across all reports

Product code DTQ is FDA's classification for "Console, heart-lung machine, cardiopulmonary bypass" (cardiovascular panel), a class 2 device. 17,404 medical device reports carry this product code, 0.1% of the MAUDE database, from October 1992 to August 2026.

1,149 reports arrived in the 12 months to August 2026, up 21% from 948 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 (90.5%), other (5%) and injury (2.6%). 27 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
Terumo Advanced Perfusion System 1	4,981	0	0.2%	99.2%
Advanced Perfusion System 1	3,756	325	0.1%	99.8%
Cardiohelp	1,068	256	8.4%	87.5%
Terumo Perfusion System 8000	834	0	0.2%	99.4%
Heart Lung Machine	714	283	3.7%	95.4%
S5 Roller Pump	637	0	0.6%	73.2%
Terumo Advanced Perfusion System One	455	0	0%	98.3%
Rotaflow Centrifugal Pump System	369	0	1.9%	79.6%
Hl-20 Integrated Perfusion System	270	0	0.4%	88.9%
S5 System	249	2	2%	92%
Cardiohelp System	245	0	3.6%	88.7%
S5 Double Head Pump	150	0	0%	67.7%
S3 Roller Pump	139	0	1.4%	39.2%
S5 Mast Roller Pump	75	9	0%	75.3%
Sarns 8000 Perfusion System	47	0	0%	98.7%
Terumo Centrifugal System	27	0	0.4%	98.9%
Quantum	15	35	0.5%	66.7%
Dual Cooler/Heater	11	0	0%	100%
Terumo Cdi 540 Calibrator	5	0	0%	100%
Heater-Cooler System 3t	4	8	3.5%	88%
S5 Gas Blender System	4	0	0%	90.6%
Terumo	4	0	2.8%	12.2%
Autopulse Resuscitation System Model 100	3	0	2.8%	96%
Maquet Hcu30 Device	2	0	1%	78.6%
Tubing Set	2	104	14%	74.4%
Cdi Blood Parameter Monitoring System 500	1	0	0%	96.1%
Sorin Heater-Cooler System 3t	1	0	2.2%	30.4%

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
Terumo Cardiovascular Systems	9,949	57.2%
Maquet Cardiopulmonary	3,174	18.2%
Sorin Group Deutschland	1,717	9.9%
Livanova Deutschland	1,304	7.5%
Terumo Cardiovascular System	720	4.1%
Maquet Critical Care	30	0.2%
Maquet	18	0.1%
Perfusion Systems	11	0.1%
Terumo	8	0%
Maquet Cardiovascular	7	0%
Livanova USA	4	0%
Terumo Medical	3	0%
Zoll Circulation	3	0%
Medtronic Perfusion Systems	2	0%
3m Health Care	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

Death1.5%266

Injury2.6%444

Malfunction90.5%15,744

Other5%864

Not given0.5%86

Who filed

Manufacturer report98.1%17,082

Voluntary report0.3%58

User facility report0%0

Distributor report0.9%165

Not given0.6%99

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

Device problems coded

Device problem (FDA code)	Reports	Share
Device displays incorrect message	1,655	9.5%
Pumping stopped	1,262	7.3%
Device operates differently than expectedthe device behaved unexpectedly	1,012	5.8%
Output problem	930	5.3%
Other (for use when an appropriate device code cannot be identified)	734	4.2%
Pumping problem	677	3.9%
No display/image	660	3.8%
Device alarm system	570	3.3%
Malfunction	530	3%
Display or visual feedback problem	458	2.6%
Failure to calibrate	453	2.6%
Breakthe device broke	451	2.6%
Battery problema problem with the battery	438	2.5%
Difficult to open or close	336	1.9%
Mechanical problema mechanical problem	334	1.9%
Sensor problems	305	1.8%
Failure to power up	302	1.7%
Monitor failure	264	1.5%
Pressure problem	263	1.5%
Calibration problem	253	1.5%

Questions about console, heart-lung machine, cardiopulmonary bypass reports

What is product code DTQ?

FDA's classification code for "Console, heart-lung machine, 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?

17,404 reports through August 2026, 1,149 of them in the latest 12 months.

Which brands appear most often?

Terumo Advanced Perfusion System 1 (4,981), Advanced Perfusion System 1 (3,756), Cardiohelp (1,068), Terumo Perfusion System 8000 (834) and Heart Lung Machine (714). 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.