Devices › Console, heart-lung machine, cardiopulmonary bypass
Device brand name · Heart lung console
Terumo Advanced Perfusion System One: medical device reports filed with FDA
461 reports name it, 2005–2010. Manufacturer given most often on reports: Terumo Cardiovascular Systems. Product code DTQ.
- 461
- device reports naming the brand
- 0% of all MAUDE reports · about 22 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 98.3%
- classified as malfunction
- 90.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 461 reports that name the brand "Terumo Advanced Perfusion System One" (heart lung console), received between June 2005 and November 2010; 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 (98.3%) and injury (1.1%); across all console, heart-lung machine, cardiopulmonary bypass reports (product code DTQ) death is recorded in 1.5% and malfunction in 90.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device displays incorrect message (13.4%), sensor problems (12.1%) and alarm system, failure of message-battery status (10.2%). The patient problems coded most often are no patient involvement, therapy/non-surgical treatment, additional 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
No report naming Terumo Advanced Perfusion System One was received in the five years to August 2026; the latest was received in November 2010.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 17,404 reports carrying product code DTQ. 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 |
|---|---|---|---|
| Device displays incorrect message | 62 | 13.4% | 9.5% |
| Sensor problems | 56 | 12.1% | 1.8% |
| Alarm system, failure of message-battery status | 47 | 10.2% | 0.4% |
| Computer failure | 42 | 9.1% | 0.4% |
| Pumping stopped | 35 | 7.6% | 7.3% |
| Loss of powerthe device lost power | 32 | 6.9% | 1% |
| Replace | 32 | 6.9% | 0.4% |
| Battery failure | 27 | 5.9% | 0.8% |
| Gas delivery system failure | 22 | 4.8% | 0.7% |
| Alarm, audible | 19 | 4.1% | 0.4% |
| Battery charger, defective | 19 | 4.1% | 0.8% |
| Use of incorrect control/treatment settings | 18 | 3.9% | 0.2% |
| Failure to pump | 16 | 3.5% | 1% |
| False alarm | 14 | 3% | 1.2% |
| No display/image | 13 | 2.8% | 3.8% |
| Repair | 13 | 2.8% | 0.1% |
| Device issuea problem with the device | 12 | 2.6% | 0.2% |
| Failure to charge | 10 | 2.2% | 0.4% |
| Other (for use when an appropriate device code cannot be identified) | 10 | 2.2% | 4.2% |
| Failure to calibrate | 8 | 1.7% | 2.6% |
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 | 11 | 2.4% |
| Therapy/non-surgical treatment, additional | 5 | 1.1% |
| Deaththe patient died; cause not stated by this term | 1 | 0.2% |
| Manual ventilation required | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Terumo Advanced Perfusion System One | Product code DTQ | All MAUDE reports |
|---|---|---|---|
| Reports | 461 | 17,404 | 26,136,888 |
| Share of that pool | — | 2.6% | 0% |
| Classified as death, per 1,000 reports | 0 | 15 | 9 |
| Classified as injury | 1.1% | 2.6% | 36.2% |
| Classified as malfunction | 98.3% | 90.5% | 62.3% |
| Filed by the manufacturer | 100% | 98.1% | 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 DTQ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Terumo Advanced Perfusion System 1 | 5,074 | 0 | 0.2% |
| Advanced Perfusion System 1 | 3,756 | 325 | 0.1% |
| Cardiohelp | 1,069 | 256 | 8.4% |
| Terumo Perfusion System 8000 | 1,376 | 0 | 0.2% |
| Heart Lung Machine | 1,873 | 283 | 3.7% |
| S5 Roller Pump | 1,178 | 0 | 0.6% |
| Rotaflow Centrifugal Pump System | 592 | 0 | 1.9% |
| Hl-20 Integrated Perfusion System | 270 | 0 | 0.4% |
| S5 System | 251 | 2 | 2% |
| Cardiohelp System | 248 | 0 | 3.6% |
| S5 Double Head Pump | 412 | 0 | 0% |
| S3 Roller Pump | 209 | 0 | 1.4% |
| S5 Mast Roller Pump | 223 | 9 | 0% |
| Sarns 8000 Perfusion System | 152 | 0 | 0% |
| Terumo Centrifugal System | 465 | 0 | 0.4% |
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." 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 Terumo Advanced Perfusion System One reports
How many FDA reports name Terumo Advanced Perfusion System One?
461 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 (98.3%) and injury (1.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device displays incorrect message (13.4%), sensor problems (12.1%), alarm system, failure of message-battery status (10.2%), computer failure (9.1%) and pumping stopped (7.6%). 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 Terumo Advanced Perfusion System One 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.