Devices › Oxygenator, cardiopulmonary bypass
Device brand name · Oxygenator cardiopulmonary bypass
Capiox Fx Oxygenator: medical device reports filed with FDA
409 reports name it, 2011–2025. Manufacturer given most often on reports: Terumo Ashitaka. Product code DTZ.
- 409
- device reports naming the brand
- 0% of all MAUDE reports · about 27 a year
- 0
- reports, 12 months to August 2026
- 19 in the 12 months before
- 74.6%
- classified as malfunction
- 78.2% across the product code
- 1.5%
- classified as death, as reported
- 6 reports · not verified by FDA
FDA's MAUDE database holds 409 reports that name the brand "Capiox Fx Oxygenator" (oxygenator cardiopulmonary bypass), received between March 2011 and May 2025; the manufacturer given most often on reports is Terumo Ashitaka. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, against 19 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 (74.6%), injury (22%) and death (1.5%); across all oxygenator, cardiopulmonary bypass reports (product code DTZ) death is recorded in 4.2% and malfunction in 78.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are leak/splash (19.6%), increase in pressure (11%) and infusion or flow problem (7.1%). 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 10,703 reports carrying product code DTZ. 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 | 80 | 19.6% | 16.8% |
| Increase in pressure | 45 | 11% | 7% |
| Infusion or flow problema problem with flow or infusion | 29 | 7.1% | 2.5% |
| Breakthe device broke | 28 | 6.8% | 3.3% |
| Detachment of device or device componentpart of the device came off | 21 | 5.1% | 0.6% |
| Pressure problem | 20 | 4.9% | 2.8% |
| Coagulation in device or device ingredient | 12 | 2.9% | 1.2% |
| Connection problema connection problem | 12 | 2.9% | 0.7% |
| Material deformation | 10 | 2.4% | 1.1% |
| Fracturea broken bone | 9 | 2.2% | 0.8% |
| Gas output problem | 8 | 2% | 3.4% |
| Device damaged prior to usethe device was damaged before use | 6 | 1.5% | 1.5% |
| Device issuea problem with the device | 6 | 1.5% | 1.3% |
| Air leak | 5 | 1.2% | 1.1% |
| Device difficult to setup or prepare | 5 | 1.2% | 0.2% |
| Device operational issue | 5 | 1.2% | 0.3% |
| Filtration problem | 5 | 1.2% | 0.5% |
| Fluid/blood leak | 5 | 1.2% | 23.8% |
| Gas/air leak | 5 | 1.2% | 0.5% |
| Insufficient flow or under infusion | 5 | 1.2% | 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 | 60 | 14.7% |
| Blood loss | 46 | 11.2% |
| Deaththe patient died; cause not stated by this term | 6 | 1.5% |
| Extubate | 2 | 0.5% |
| Hemorrhage/blood loss/bleeding | 1 | 0.2% |
| High blood pressure/ hypertension | 1 | 0.2% |
| Muscle/tendon damage | 1 | 0.2% |
| Myocardial infarctionheart attack | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Capiox Fx Oxygenator | Product code DTZ | All MAUDE reports |
|---|---|---|---|
| Reports | 409 | 10,703 | 26,136,888 |
| Share of that pool | — | 3.8% | 0% |
| Classified as death, per 1,000 reports | 15 | 42 | 9 |
| Classified as injury | 22% | 14.5% | 36.2% |
| Classified as malfunction | 74.6% | 78.2% | 62.3% |
| Filed by the manufacturer | 99.8% | 93.3% | 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 DTZ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Fusion Hollow Fiber Oxygenator | 1,515 | 996 | 0.7% |
| Tubing Set | 336 | 104 | 14% |
| Sterile Fx25rwc W/ Res | 279 | 0 | 2.5% |
| Sterile Fx25rec W/Res | 277 | 0 | 1.4% |
| Affinity Nt Balance | 271 | 150 | 0.4% |
| Oxygenator Cardiopulmonary Bypass | 274 | 0 | 4.7% |
| Hls Set Advanced | 215 | 0 | 12.1% |
| Capiox FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. | 160 | 68 | 6.3% |
| Hlm Tubing Set W/Bioline Coating | 439 | 0 | 7.1% |
| Navilyst Medical | 252 | 0 | 0.4% |
| Cardiovascular Procedure Kit | 553 | 0 | 1.3% |
| Shunt Sensor Sys500 | 712 | 0 | 0.1% |
| AngioDynamics | 174 | 14 | 1.7% |
| Heart Lung Machine | 1,873 | 283 | 3.7% |
| Apex | 876 | 78 | 1.3% |
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 Capiox Fx Oxygenator reports
How many FDA reports name Capiox Fx Oxygenator?
409 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 (74.6%), injury (22%) and death (1.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
leak/splash (19.6%), increase in pressure (11%), infusion or flow problem (7.1%), break (6.8%) and detachment of device or device component (5.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Capiox Fx Oxygenator 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.