Devices › Pump, blood, cardiopulmonary bypass, non-roller type
Device brand name · Pump blood cardiopulmonary bypass non-roller type
Heart Lung Machine: medical device reports filed with FDA
1,873 reports name it, 2009–2026. Manufacturer given most often on reports: Maquet Cardiopulmonary. Product code KFM.
- 1,873
- device reports naming the brand
- 0% of all MAUDE reports · about 110 a year
- 283
- reports, 12 months to August 2026
- 342 in the 12 months before
- 95.4%
- classified as malfunction
- 74.8% across the product code
- 3.7%
- classified as death, as reported
- 69 reports · not verified by FDA
1,873 medical device reports received by FDA name the brand "Heart Lung Machine" (pump blood cardiopulmonary bypass non-roller type); the manufacturer given most often on reports is Maquet Cardiopulmonary; received from July 2009 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
283 reports arrived in the 12 months to August 2026, down 17% from 342 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 (95.4%), death (3.7%) and injury (1%); 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 electrical /electronic property problem (30.3%), pumping problem (24.6%) and pumping stopped (16.3%). The patient problems coded most often are no patient involvement, death 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 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 |
|---|---|---|---|
| Electrical /electronic property probleman electrical or electronic problem | 568 | 30.3% | 13.3% |
| Pumping problem | 461 | 24.6% | 3.2% |
| Pumping stopped | 305 | 16.3% | 9.8% |
| Device displays incorrect message | 115 | 6.1% | 7% |
| Battery problema problem with the battery | 103 | 5.5% | 4.2% |
| Failure to pump | 53 | 2.8% | 0.8% |
| Inaccurate flow rate | 47 | 2.5% | 1.1% |
| Overheating of device | 43 | 2.3% | 3.3% |
| Infusion or flow problema problem with flow or infusion | 40 | 2.1% | 4.3% |
| Communication or transmission problemthe device could not communicate or transmit | 29 | 1.5% | 1.3% |
| Mechanical problema mechanical problem | 28 | 1.5% | 4.5% |
| Device sensing problem | 20 | 1.1% | 0.1% |
| Display or visual feedback problem | 17 | 0.9% | 0.4% |
| Increased pump speed | 16 | 0.9% | 0.4% |
| No flow | 16 | 0.9% | 1.2% |
| No display/image | 12 | 0.6% | 1.3% |
| Pressure problem | 12 | 0.6% | 0% |
| Insufficient device problem information | 10 | 0.5% | 6.9% |
| Improper flow or infusion | 9 | 0.5% | 0.5% |
| Noise, audible | 8 | 0.4% | 10.8% |
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 | 89 | 4.8% |
| Deaththe patient died; cause not stated by this term | 16 | 0.9% |
| Cardiac arrestthe heart stopped | 14 | 0.7% |
| Sepsisa severe body-wide response to infection | 4 | 0.2% |
| Hypoxialow oxygen | 3 | 0.2% |
| Adult respiratory distress syndrome | 2 | 0.1% |
| Aneurysm | 2 | 0.1% |
| Apnea | 2 | 0.1% |
| Congenital defect/deformity | 2 | 0.1% |
| High blood pressure/ hypertension | 2 | 0.1% |
| Hypovolemia | 2 | 0.1% |
| Low oxygen saturation | 2 | 0.1% |
| Myocarditisinflammation of the heart muscle | 2 | 0.1% |
| Respiratory arrestbreathing stopped | 2 | 0.1% |
| Septic shockshock arising from infection | 2 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Heart Lung Machine | Product code KFM | All MAUDE reports |
|---|---|---|---|
| Reports | 1,873 | 4,387 | 26,136,888 |
| Share of that pool | — | 42.7% | 0% |
| Classified as death, per 1,000 reports | 37 | 58 | 9 |
| Classified as injury | 1% | 17.7% | 36.2% |
| Classified as malfunction | 95.4% | 74.8% | 62.3% |
| Filed by the manufacturer | 97.9% | 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 |
|---|---|---|---|
| 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% |
| CentriMag Blood Pump | 279 | 39 | 17.2% |
| 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 Heart Lung Machine reports
How many FDA reports name Heart Lung Machine?
1,873 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 283 in the latest 12 months.
What kinds of events are reported?
malfunction (95.4%), death (3.7%) and injury (1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
electrical /electronic property problem (30.3%), pumping problem (24.6%), pumping stopped (16.3%), device displays incorrect message (6.1%) and battery problem (5.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (97.9%) and distributor reports (2.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Heart Lung Machine 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.