Devices › Pump, blood, cardiopulmonary bypass, non-roller type
Device brand name · Centrifugal pump
Sarns Centrifugal Pump: medical device reports filed with FDA
188 reports name it, 2001–2014. Manufacturer given most often on reports: Terumo Cardiovascular Systems. Product code KFM.
- 188
- device reports naming the brand
- 0% of all MAUDE reports · about 7 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 81.9%
- classified as malfunction
- 74.8% across the product code
- 1.1%
- classified as death, as reported
- 2 reports · not verified by FDA
188 medical device reports received by FDA name the brand "Sarns Centrifugal Pump" (centrifugal pump); the manufacturer given most often on reports is Terumo Cardiovascular Systems; received from April 2001 to September 2014. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 (81.9%), injury (6.4%) and other (3.2%); 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 noise, audible (22.9%), fluid/blood leak (19.1%) and leak/splash (8.5%). The patient problems coded most often are no patient involvement, blood loss 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 Sarns Centrifugal Pump was received in the five years to August 2026; the latest was received in September 2014.
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 |
|---|---|---|---|
| Noise, audible | 43 | 22.9% | 10.8% |
| Fluid/blood leak | 36 | 19.1% | 3.4% |
| Leak/splashthe device leaked | 16 | 8.5% | 3.7% |
| Disconnection | 15 | 8% | 0.8% |
| Mechanical problema mechanical problem | 12 | 6.4% | 4.5% |
| Malfunction | 10 | 5.3% | 0.4% |
| Noise | 7 | 3.7% | 0.7% |
| Bubble(s) | 5 | 2.7% | 0.2% |
| Failure to pump | 5 | 2.7% | 0.8% |
| Device issuea problem with the device | 3 | 1.6% | 0.5% |
| Device operates differently than expectedthe device behaved unexpectedly | 3 | 1.6% | 2% |
| Failure to prime | 3 | 1.6% | 0.1% |
| Material separation | 3 | 1.6% | 0.2% |
| Air leak | 2 | 1.1% | 0.3% |
| Breakthe device broke | 2 | 1.1% | 1.2% |
| Crackthe device cracked | 2 | 1.1% | 1.6% |
| Decreased pump speed | 2 | 1.1% | 0.8% |
| Deprimed | 2 | 1.1% | 0% |
| Device contamination with chemical or other material | 2 | 1.1% | 0.2% |
| Improper flow or infusion | 2 | 1.1% | 0.5% |
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 | 81 | 43.1% |
| Blood loss | 26 | 13.8% |
| Deaththe patient died; cause not stated by this term | 2 | 1.1% |
| Low blood pressure/ hypotension | 2 | 1.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Sarns Centrifugal Pump | Product code KFM | All MAUDE reports |
|---|---|---|---|
| Reports | 188 | 4,387 | 26,136,888 |
| Share of that pool | — | 4.3% | 0% |
| Classified as death, per 1,000 reports | 11 | 58 | 9 |
| Classified as injury | 6.4% | 17.7% | 36.2% |
| Classified as malfunction | 81.9% | 74.8% | 62.3% |
| Filed by the manufacturer | 99.5% | 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% |
| CentriMag Blood Pump | 279 | 39 | 17.2% |
| 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 Sarns Centrifugal Pump reports
How many FDA reports name Sarns Centrifugal Pump?
188 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 (81.9%), injury (6.4%) and other (3.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
noise, audible (22.9%), fluid/blood leak (19.1%), leak/splash (8.5%), disconnection (8%) and mechanical problem (6.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Sarns Centrifugal 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.