Monitor, blood-gas, on-line, cardiopulmonary bypass: medical device reports filed with FDA

5,039 reports carry this product code, 1992–2026; 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.

5,039
reports with this product code: 0% of all MAUDE reports; 134
reports, 12 months to August 2026: 137 in the 12 months before; 94.3%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

Product code DRY is FDA's classification for "Monitor, blood-gas, on-line, cardiopulmonary bypass" (cardiovascular panel), a class 2 device. 5,039 medical device reports carry this product code, 0% of the MAUDE database, from July 1992 to August 2026.

134 reports arrived in the 12 months to August 2026, close to the 137 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 (94.3%), other (1%) and injury (0.5%). 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
Terumo Cdi 500 Blood Parameter Monitor	2,765	0	0%	98.3%
Shunt Sensor Sys500	703	0	0.1%	71.3%
Terumo Cdi 540 Calibrator	595	0	0%	100%
Cdi Blood Parameter Monitoring System 500	336	0	0%	96.1%
Quantum	3	35	0.5%	66.7%
Bulk Non Ster Xcoat Delph Pump	1	0	0.4%	97%
Capiox Fx Oxygenator	1	0	1.5%	74.6%
Sarns Centrifugal Pump	1	0	1.1%	81.9%
Terumo Advanced Perfusion System 1	1	0	0.2%	99.2%
Terumo Cdi 100 Monitor	1	0	0%	100%
Terumo Perfusion System 8000	1	0	0.2%	99.4%

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	4,141	82.2%
Terumo Cardiovascular System	637	12.6%
Maquet Cardiopulmonary	6	0.1%
Agilent Technologies	1	0%
Sorin Group Italia	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

Death0.2%8

Injury0.5%25

Malfunction94.3%4,753

Other1%52

Not given4%201

Who filed

Manufacturer report99.9%5,035

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0.1%4

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

Device problems coded

Device problem (FDA code)	Reports	Share
Incorrect, inadequate or imprecise result or readings	697	13.8%
Leak/splashthe device leaked	608	12.1%
Device displays incorrect message	539	10.7%
Breakthe device broke	417	8.3%
Device operates differently than expectedthe device behaved unexpectedly	341	6.8%
Battery problema problem with the battery	165	3.3%
Connection problema connection problem	152	3%
Crackthe device cracked	143	2.8%
Fracturea broken bone	135	2.7%
Naturally worn	123	2.4%
Incorrect or inadequate test results	116	2.3%
Failure of device to self-test	103	2%
Failure to calibrate	95	1.9%
Failure to power up	77	1.5%
Device sensing problem	70	1.4%
Scratched material	70	1.4%
Calibration error	64	1.3%
Fluid/blood leak	63	1.3%
Output problem	57	1.1%
Corrodedthe device corroded	51	1%

Questions about monitor, blood-gas, on-line, cardiopulmonary bypass reports

What is product code DRY?

FDA's classification code for "Monitor, blood-gas, on-line, 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?

5,039 reports through August 2026, 134 of them in the latest 12 months.

Which brands appear most often?

Terumo Cdi 500 Blood Parameter Monitor (2,765), Shunt Sensor Sys500 (703), Terumo Cdi 540 Calibrator (595), Cdi Blood Parameter Monitoring System 500 (336) and Quantum (3). 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.