Devices › Monitor, blood-gas, on-line, cardiopulmonary bypass
Device brand name · Blood-gas monitor
Shunt Sensor Sys500: medical device reports filed with FDA
712 reports name it, 2010–2023. Manufacturer given most often on reports: Terumo Cardiovascular Systems. Product code DRY.
- 712
- device reports naming the brand
- 0% of all MAUDE reports · about 44 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 71.3%
- classified as malfunction
- 94.3% across the product code
- 0.1%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 712 reports that name the brand "Shunt Sensor Sys500" (blood-gas monitor), received between May 2010 and November 2023; the manufacturer given most often on reports is Terumo Cardiovascular Systems. Spellings of one product vary from report to report.
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 (71.3%), injury (1.8%) and other (0.6%); across all monitor, blood-gas, on-line, cardiopulmonary bypass reports (product code DRY) death is recorded in 0.2% and malfunction in 94.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are leak/splash (73.2%), calibration error (8%) and fluid/blood leak (6.5%). The patient problems coded most often are no patient involvement, blood loss 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 5,039 reports carrying product code DRY. 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 |
|---|---|---|---|
| Leak/splashthe device leaked | 521 | 73.2% | 12.1% |
| Calibration error | 57 | 8% | 1.3% |
| Fluid/blood leak | 46 | 6.5% | 1.3% |
| Failure to calibrate | 14 | 2% | 1.9% |
| Device issuea problem with the device | 12 | 1.7% | 0.3% |
| Calibration problem | 8 | 1.1% | 0.6% |
| Improper flow or infusion | 4 | 0.6% | 0.1% |
| Incorrect, inadequate or imprecise result or readings | 4 | 0.6% | 13.8% |
| No flow | 4 | 0.6% | 0.1% |
| Out-of-box failure | 4 | 0.6% | 0.1% |
| Crackthe device cracked | 3 | 0.4% | 2.8% |
| Device sensing problem | 3 | 0.4% | 1.4% |
| Device contamination with chemical or other material | 2 | 0.3% | 0.2% |
| Fitting problem | 2 | 0.3% | 0.3% |
| Breakthe device broke | 1 | 0.1% | 8.3% |
| Connection problema connection problem | 1 | 0.1% | 3% |
| Device damaged prior to usethe device was damaged before use | 1 | 0.1% | 0.4% |
| Failure to recalibrate | 1 | 0.1% | 0% |
| High readingsreadings were too high | 1 | 0.1% | 0.6% |
| Resistance, loss of | 1 | 0.1% | 0% |
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 | 338 | 47.5% |
| Blood loss | 288 | 40.4% |
| Deaththe patient died; cause not stated by this term | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Shunt Sensor Sys500 | Product code DRY | All MAUDE reports |
|---|---|---|---|
| Reports | 712 | 5,039 | 26,136,888 |
| Share of that pool | — | 14.1% | 0% |
| Classified as death, per 1,000 reports | 1 | 2 | 9 |
| Classified as injury | 1.8% | 0.5% | 36.2% |
| Classified as malfunction | 71.3% | 94.3% | 62.3% |
| Filed by the manufacturer | 100% | 99.9% | 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 DRY
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Terumo Cdi 500 Blood Parameter Monitor | 2,769 | 0 | 0% |
| Terumo Cdi 540 Calibrator | 601 | 0 | 0% |
| Cdi Blood Parameter Monitoring System 500 | 337 | 0 | 0% |
| Quantum | 183 | 35 | 0.5% |
| Bulk Non Ster Xcoat Delph Pump | 266 | 0 | 0.4% |
| Capiox Fx Oxygenator | 409 | 0 | 1.5% |
| Sarns Centrifugal Pump | 188 | 0 | 1.1% |
| Terumo Advanced Perfusion System 1 | 5,074 | 0 | 0.2% |
| Terumo Cdi 100 Monitor | 183 | 0 | 0% |
| Terumo Perfusion System 8000 | 1,376 | 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 Shunt Sensor Sys500 reports
How many FDA reports name Shunt Sensor Sys500?
712 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 (71.3%), injury (1.8%) and other (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
leak/splash (73.2%), calibration error (8%), fluid/blood leak (6.5%), failure to calibrate (2%) and device issue (1.7%). 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 Shunt Sensor Sys500 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.