Pump, blood, cardiopulmonary bypass, non-roller type: medical device reports filed with FDA

4,387 reports carry this product code, 1992–2026; 18 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

4,387
reports with this product code: 0% of all MAUDE reports; 253
reports, 12 months to August 2026: 270 in the 12 months before; 74.8%
classified as malfunction: 62.3% across all reports; 5.8%
classified as death, as reported: 0.9% across all reports

Product code KFM is FDA's classification for "Pump, blood, cardiopulmonary bypass, non-roller type" (cardiovascular panel), a class 2 device. 4,387 medical device reports carry this product code, 0% of the MAUDE database, from July 1992 to August 2026.

253 reports arrived in the 12 months to August 2026, close to the 270 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 (74.8%), injury (17.7%) and death (5.8%). 18 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Heart Lung Machine	1,154	283	3.7%	95.4%
CentriMag Motor, US	418	84	0.8%	75.3%
Bulk Non Ster Xcoat Delph Pump	264	0	0.4%	97%
CentriMag Motor, OUS	239	39	1.4%	77.2%
Rotaflow Centrifugal Pump System	223	0	1.9%	79.6%
CentriMag Blood Pump	196	39	17.2%	20.1%
Sarns Centrifugal Pump	184	0	1.1%	81.9%
Terumo Centrifugal System	121	0	0.4%	98.9%
Impella CP	22	2,463	12.9%	27.8%
Impella	19	8,251	15.2%	40.4%
Impella 2 5	7	0	11.9%	33%
Impella 5 0	2	3	22.3%	32.8%
Automated Impella Controller	1	455	5.6%	93.4%
Cardiohelp System	1	0	3.6%	88.7%
Centrifugal Pump System With Tubing Clamp	1	0	0.6%	95.2%
Hls Set Advanced	1	0	12.1%	84.7%
Impella Cp Pump Set	1	0	3.6%	1.2%
Terumo Advanced Perfusion System 1	1	0	0.2%	99.2%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Maquet Cardiopulmonary	1,520	34.6%
Thoratec Switzerland	1,055	24%
Terumo Cardiovascular Systems	816	18.6%
Abiomed	100	2.3%
Livanova Deutschland	91	2.1%
Perfusion Systems	63	1.4%
Sorin Group Italia	51	1.2%
Medtronic Perfusion Systems	50	1.1%
Thoratec	45	1%
Sorin Group Deutschland	34	0.8%
Maquet	11	0.3%
Terumo Cardiovascular System	11	0.3%
Terumo Ashitaka	5	0.1%
Terumo Medical	4	0.1%
Datascope	3	0.1%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death5.8%254

Injury17.7%775

Malfunction74.8%3,281

Other0.6%25

Not given1.2%52

Who filed

Manufacturer report93.1%4,083

Voluntary report1.6%70

User facility report0%0

Distributor report2.4%106

Not given2.9%128

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Electrical /electronic property probleman electrical or electronic problem	583	13.3%
Noise, audible	473	10.8%
Pumping stopped	431	9.8%
Device displays incorrect message	309	7%
Insufficient device problem information	302	6.9%
Mechanical problema mechanical problem	197	4.5%
Infusion or flow problema problem with flow or infusion	189	4.3%
Battery problema problem with the battery	184	4.2%
Leak/splashthe device leaked	164	3.7%
Fluid/blood leak	149	3.4%
Overheating of device	146	3.3%
Pumping problem	140	3.2%
Replace	102	2.3%
Unexpected shutdown	89	2%
Device operates differently than expectedthe device behaved unexpectedly	87	2%
Crackthe device cracked	69	1.6%
Communication or transmission problemthe device could not communicate or transmit	58	1.3%
No display/image	56	1.3%
Breakthe device broke	53	1.2%
No flow	53	1.2%

Questions about pump, blood, cardiopulmonary bypass, non-roller type reports

What is product code KFM?

FDA's classification code for "Pump, blood, cardiopulmonary bypass, non-roller type", class 2, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.

How many reports carry this code?

4,387 reports through August 2026, 253 of them in the latest 12 months.

Which brands appear most often?

Heart Lung Machine (1,154), CentriMag Motor, US (418), Bulk Non Ster Xcoat Delph Pump (264), CentriMag Motor, OUS (239) and Rotaflow Centrifugal Pump System (223). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.