Devices › Control, pump speed, cardiopulmonary bypass
Device brand name · Control pump speed cardiopulmonary bypass
Bio Console 560: medical device reports filed with FDA
590 reports name it, 2014–2026. Manufacturer given most often on reports: Perfusion Systems. Product code DWA.
- 590
- device reports naming the brand
- 0% of all MAUDE reports · about 48 a year
- 108
- reports, 12 months to August 2026
- 103 in the 12 months before
- 92.4%
- classified as malfunction
- 81% across the product code
- 0.2%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 590 reports that name the brand "Bio Console 560" (control pump speed cardiopulmonary bypass), received between April 2014 and August 2026; the manufacturer given most often on reports is Perfusion Systems. Spellings of one product vary from report to report.
108 reports arrived in the 12 months to August 2026, close to the 103 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 (92.4%), injury (7.5%) and death (0.2%); across all control, pump speed, cardiopulmonary bypass reports (product code DWA) death is recorded in 1.4% and malfunction in 81%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are battery problem (42%), device alarm system (29.2%) and power problem (23.4%). The patient problems coded most often are hypoxia and low blood pressure/ hypotension. 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 3,495 reports carrying product code DWA. 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 |
|---|---|---|---|
| Battery problema problem with the battery | 248 | 42% | 9.9% |
| Device alarm system | 172 | 29.2% | 6.6% |
| Power problem | 138 | 23.4% | 6.6% |
| Electrical /electronic property probleman electrical or electronic problem | 37 | 6.3% | 4.5% |
| Display or visual feedback problem | 32 | 5.4% | 3.3% |
| Obstruction of flow | 28 | 4.7% | 1.2% |
| Smoking | 22 | 3.7% | 1% |
| Material deformation | 12 | 2% | 0.5% |
| Mechanical problema mechanical problem | 12 | 2% | 4.1% |
| Pumping problem | 11 | 1.9% | 3.1% |
| Noise, audible | 6 | 1% | 3.3% |
| Infusion or flow problema problem with flow or infusion | 5 | 0.8% | 5.5% |
| Component missing | 3 | 0.5% | 0.3% |
| Connection problema connection problem | 3 | 0.5% | 0.3% |
| Increase in pressure | 3 | 0.5% | 0.2% |
| Calibration problem | 1 | 0.2% | 0.1% |
| Computer software problema software problem | 1 | 0.2% | 0.2% |
| Excess flow or over-infusion | 1 | 0.2% | 0% |
| Failure to power up | 1 | 0.2% | 1.3% |
| Fluid/blood leak | 1 | 0.2% | 0.1% |
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 |
|---|---|---|
| Hypoxialow oxygen | 1 | 0.2% |
| Low blood pressure/ hypotension | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Bio Console 560 | Product code DWA | All MAUDE reports |
|---|---|---|---|
| Reports | 590 | 3,495 | 26,136,888 |
| Share of that pool | — | 16.9% | 0% |
| Classified as death, per 1,000 reports | 2 | 14 | 9 |
| Classified as injury | 7.5% | 12.6% | 36.2% |
| Classified as malfunction | 92.4% | 81% | 62.3% |
| Filed by the manufacturer | 100% | 97.7% | 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 DWA
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| CentriMag 2nd Generation Primary Console | 684 | 120 | 0.3% |
| Terumo Centrifugal System | 465 | 0 | 0.4% |
| Centrifugal Pump 5 Cp5 | 186 | 0 | 1.6% |
| Centrifugal Pump System With Tubing Clamp | 167 | 0 | 0.6% |
| CentriMag Motor, US | 663 | 84 | 0.8% |
| CentriMag Motor, OUS | 351 | 39 | 1.4% |
| Heater-Cooler System 3t | 3,380 | 8 | 3.5% |
| Terumo Advanced Perfusion System 1 | 5,074 | 0 | 0.2% |
| Sarns Centrifugal Pump | 188 | 0 | 1.1% |
| Automated Impella Controller Aic | 224 | 0 | 3.6% |
| CentriMag Blood Pump | 279 | 39 | 17.2% |
| Impella | 8,457 | 8,251 | 15.2% |
| Impella Rp | 1,135 | 94 | 14.9% |
| S5 Double Head Pump | 412 | 0 | 0% |
| Sarns 8000 Perfusion System | 152 | 0 | 0% |
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 Bio Console 560 reports
How many FDA reports name Bio Console 560?
590 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 108 in the latest 12 months.
What kinds of events are reported?
malfunction (92.4%), injury (7.5%) and death (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
battery problem (42%), device alarm system (29.2%), power problem (23.4%), electrical /electronic property problem (6.3%) and display or visual feedback problem (5.4%). 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 Bio Console 560 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.