Devices › Pump, blood, cardiopulmonary bypass, non-roller type
Device brand name · Pump blood cardiopulmonary bypass non-roller type
CentriMag Blood Pump: medical device reports filed with FDA
279 reports name it, 2018–2026. Manufacturer given most often on reports: Thoratec Switzerland. Product code KFM.
- 279
- device reports naming the brand
- 0% of all MAUDE reports · about 35 a year
- 39
- reports, 12 months to August 2026
- 39 in the 12 months before
- 20.1%
- classified as malfunction
- 74.8% across the product code
- 17.2%
- classified as death, as reported
- 48 reports · not verified by FDA
FDA's MAUDE database holds 279 reports that name the brand "CentriMag Blood Pump" (pump blood cardiopulmonary bypass non-roller type), received between June 2018 and August 2026; the manufacturer given most often on reports is Thoratec Switzerland. Spellings of one product vary from report to report.
39 reports arrived in the 12 months to August 2026, close to the 39 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 injury (62.7%), malfunction (20.1%) and death (17.2%); across all pump, blood, cardiopulmonary bypass, non-roller type reports (product code KFM) death is recorded in 5.8% and malfunction in 74.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are mechanical problem (12.5%), infusion or flow problem (8.6%) and noise, audible (8.2%). The patient problems coded most often are hemorrhage/blood loss/bleeding, thrombosis/thrombus and heart failure/congestive heart failure. 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 4,387 reports carrying product code KFM. 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 |
|---|---|---|---|
| Mechanical problema mechanical problem | 35 | 12.5% | 4.5% |
| Infusion or flow problema problem with flow or infusion | 24 | 8.6% | 4.3% |
| Noise, audible | 23 | 8.2% | 10.8% |
| Insufficient device problem information | 12 | 4.3% | 6.9% |
| Device difficult to setup or prepare | 10 | 3.6% | 0.7% |
| Overheating of device | 5 | 1.8% | 3.3% |
| Unexpected shutdown | 5 | 1.8% | 2% |
| Fluid/blood leak | 4 | 1.4% | 3.4% |
| Decreased pump speed | 3 | 1.1% | 0.8% |
| Gas/air leak | 3 | 1.1% | 0% |
| Pumping stopped | 3 | 1.1% | 9.8% |
| Vibration | 3 | 1.1% | 0.3% |
| Communication or transmission problemthe device could not communicate or transmit | 2 | 0.7% | 1.3% |
| Contamination /decontamination problem | 2 | 0.7% | 0% |
| Electrical /electronic property probleman electrical or electronic problem | 2 | 0.7% | 13.3% |
| Excessive heating | 2 | 0.7% | 0.3% |
| Fracturea broken bone | 2 | 0.7% | 0.2% |
| Connection problema connection problem | 1 | 0.4% | 0.3% |
| Crackthe device cracked | 1 | 0.4% | 1.6% |
| Device alarm system | 1 | 0.4% | 0.4% |
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 |
|---|---|---|
| Hemorrhage/blood loss/bleeding | 53 | 19% |
| Thrombosis/thrombus | 42 | 15.1% |
| Heart failure/congestive heart failure | 24 | 8.6% |
| Bacterial infectiona bacterial infection | 22 | 7.9% |
| Renal failurekidney failure | 19 | 6.8% |
| Multiple organ dysfunction syndromeseveral organs failing | 17 | 6.1% |
| Arrhythmia | 13 | 4.7% |
| Hemolysis | 13 | 4.7% |
| Tachycardiafast heart rate | 13 | 4.7% |
| Ischemia stroke | 11 | 3.9% |
| Thromboembolism | 11 | 3.9% |
| Atrial fibrillationan irregular heart rhythm | 10 | 3.6% |
| Deaththe patient died; cause not stated by this term | 9 | 3.2% |
| Hemodynamic instability | 9 | 3.2% |
| Respiratory failurethe lungs could not supply enough oxygen | 9 | 3.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | CentriMag Blood Pump | Product code KFM | All MAUDE reports |
|---|---|---|---|
| Reports | 279 | 4,387 | 26,136,888 |
| Share of that pool | — | 6.4% | 0% |
| Classified as death, per 1,000 reports | 172 | 58 | 9 |
| Classified as injury | 62.7% | 17.7% | 36.2% |
| Classified as malfunction | 20.1% | 74.8% | 62.3% |
| Filed by the manufacturer | 99.3% | 93.1% | 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 KFM
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Heart Lung Machine | 1,873 | 283 | 3.7% |
| CentriMag Motor, US | 663 | 84 | 0.8% |
| Bulk Non Ster Xcoat Delph Pump | 266 | 0 | 0.4% |
| CentriMag Motor, OUS | 351 | 39 | 1.4% |
| Rotaflow Centrifugal Pump System | 592 | 0 | 1.9% |
| Sarns Centrifugal Pump | 188 | 0 | 1.1% |
| Terumo Centrifugal System | 465 | 0 | 0.4% |
| Impella CP | 20,624 | 2,463 | 12.9% |
| Impella | 8,457 | 8,251 | 15.2% |
| Impella 2 5 | 327 | 0 | 11.9% |
| Impella 5 0 | 628 | 3 | 22.3% |
| Automated Impella Controller | 3,792 | 455 | 5.6% |
| Cardiohelp System | 248 | 0 | 3.6% |
| Centrifugal Pump System With Tubing Clamp | 167 | 0 | 0.6% |
| Hls Set Advanced | 215 | 0 | 12.1% |
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 Blood Pump reports
How many FDA reports name CentriMag Blood Pump?
279 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 39 in the latest 12 months.
What kinds of events are reported?
injury (62.7%), malfunction (20.1%) and death (17.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
mechanical problem (12.5%), infusion or flow problem (8.6%), noise, audible (8.2%), insufficient device problem information (4.3%) and device difficult to setup or prepare (3.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that CentriMag Blood Pump 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.