Devices › Control, pump speed, cardiopulmonary bypass
Device brand name · Control pump speed cardiopulmonary bypass
CentriMag 2nd Generation Primary Console: medical device reports filed with FDA
684 reports name it, 2018–2026. Manufacturer given most often on reports: Thoratec Switzerland. Product code DWA.
- 684
- device reports naming the brand
- 0% of all MAUDE reports · about 84 a year
- 120
- reports, 12 months to August 2026
- 102 in the 12 months before
- 79.7%
- classified as malfunction
- 81% across the product code
- 0.3%
- classified as death, as reported
- 2 reports · not verified by FDA
684 medical device reports received by FDA name the brand "CentriMag 2nd Generation Primary Console" (control pump speed cardiopulmonary bypass); the manufacturer given most often on reports is Thoratec Switzerland; received from May 2018 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
120 reports arrived in the 12 months to August 2026, up 18% from 102 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 (79.7%), injury (20%) and death (0.3%); 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 insufficient device problem information (36%), infusion or flow problem (12.7%) and electrical /electronic property problem (10.7%). The patient problems coded most often are no patient involvement, low oxygen saturation and cardiac arrest. 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 |
|---|---|---|---|
| Insufficient device problem information | 246 | 36% | 10.8% |
| Infusion or flow problema problem with flow or infusion | 87 | 12.7% | 5.5% |
| Electrical /electronic property probleman electrical or electronic problem | 73 | 10.7% | 4.5% |
| Unexpected shutdown | 71 | 10.4% | 3.5% |
| Pumping stopped | 46 | 6.7% | 8.2% |
| Overheating of device | 35 | 5.1% | 1.9% |
| Display or visual feedback problem | 33 | 4.8% | 3.3% |
| Communication or transmission problemthe device could not communicate or transmit | 31 | 4.5% | 1.9% |
| Noise, audible | 31 | 4.5% | 3.3% |
| Decreased pump speed | 24 | 3.5% | 1.9% |
| No display/image | 23 | 3.4% | 3.5% |
| Failure to power up | 19 | 2.8% | 1.3% |
| Improper or incorrect procedure or method | 19 | 2.8% | 0.8% |
| Mechanical problema mechanical problem | 16 | 2.3% | 4.1% |
| Electrical power problem | 10 | 1.5% | 0.5% |
| Power problem | 7 | 1% | 6.6% |
| Device alarm system | 6 | 0.9% | 6.6% |
| Device difficult to setup or prepare | 6 | 0.9% | 0.3% |
| No flow | 6 | 0.9% | 1.1% |
| Failure of device to self-test | 5 | 0.7% | 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 |
|---|---|---|
| No patient involvement | 26 | 3.8% |
| Low oxygen saturation | 9 | 1.3% |
| Cardiac arrestthe heart stopped | 7 | 1% |
| Complaint, ill-defined | 3 | 0.4% |
| Deaththe patient died; cause not stated by this term | 3 | 0.4% |
| Bradycardiaslow heart rate | 2 | 0.3% |
| Dyspneashortness of breath | 2 | 0.3% |
| Hemodynamic instability | 2 | 0.3% |
| Hemorrhage/blood loss/bleeding | 2 | 0.3% |
| Hypoxialow oxygen | 2 | 0.3% |
| Low blood pressure/ hypotension | 2 | 0.3% |
| Respiratory insufficiency | 2 | 0.3% |
| Thrombus | 2 | 0.3% |
| Asystole | 1 | 0.1% |
| Chest painchest pain | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | CentriMag 2nd Generation Primary Console | Product code DWA | All MAUDE reports |
|---|---|---|---|
| Reports | 684 | 3,495 | 26,136,888 |
| Share of that pool | — | 19.6% | 0% |
| Classified as death, per 1,000 reports | 3 | 14 | 9 |
| Classified as injury | 20% | 12.6% | 36.2% |
| Classified as malfunction | 79.7% | 81% | 62.3% |
| Filed by the manufacturer | 99.9% | 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 |
|---|---|---|---|
| Bio Console 560 | 590 | 108 | 0.2% |
| 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 CentriMag 2nd Generation Primary Console reports
How many FDA reports name CentriMag 2nd Generation Primary Console?
684 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 120 in the latest 12 months.
What kinds of events are reported?
malfunction (79.7%), injury (20%) and death (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (36%), infusion or flow problem (12.7%), electrical /electronic property problem (10.7%), unexpected shutdown (10.4%) and pumping stopped (6.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that CentriMag 2nd Generation Primary Console 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.