Control, pump speed, cardiopulmonary bypass: medical device reports filed with FDA

3,495 reports carry this product code, 1995–2026; 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.

3,495
reports with this product code: 0% of all MAUDE reports; 342
reports, 12 months to August 2026: 343 in the 12 months before; 81%
classified as malfunction: 62.3% across all reports; 1.4%
classified as death, as reported: 0.9% across all reports

Product code DWA is FDA's classification for "Control, pump speed, cardiopulmonary bypass" (cardiovascular panel), a class 2 device. 3,495 medical device reports carry this product code, 0% of the MAUDE database, from July 1995 to August 2026.

342 reports arrived in the 12 months to August 2026, close to the 343 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 (81%), injury (12.6%) and other (4.3%). 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
CentriMag 2nd Generation Primary Console	667	120	0.3%	79.7%
Bio Console 560	590	108	0.2%	92.4%
Terumo Centrifugal System	317	0	0.4%	98.9%
Centrifugal Pump 5 Cp5	186	0	1.6%	95.7%
Centrifugal Pump System With Tubing Clamp	165	0	0.6%	95.2%
CentriMag Motor, US	130	84	0.8%	75.3%
CentriMag Motor, OUS	27	39	1.4%	77.2%
Heater-Cooler System 3t	4	8	3.5%	88%
Terumo Advanced Perfusion System 1	3	0	0.2%	99.2%
Sarns Centrifugal Pump	2	0	1.1%	81.9%
Automated Impella Controller Aic	1	0	3.6%	95.1%
CentriMag Blood Pump	1	39	17.2%	20.1%
Impella	1	8,251	15.2%	40.4%
Impella Rp	1	94	14.9%	42%
S5 Double Head Pump	1	0	0%	67.7%
Sarns 8000 Perfusion System	1	0	0%	98.7%
Terumo	1	0	2.8%	12.2%
Terumo Perfusion System 8000	1	0	0.2%	99.4%

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
Thoratec Switzerland	1,232	35.3%
Perfusion Systems	794	22.7%
Livanova Deutschland	475	13.6%
Terumo Cardiovascular Systems	375	10.7%
Sorin Group Deutschland	282	8.1%
Thoratec	75	2.1%
Terumo Cardiovascular System	71	2%
Medtronic Perfusion Systems	41	1.2%
Abiomed	4	0.1%
Maquet Critical Care	4	0.1%
Medtronic Physio-Control	2	0.1%
Livanova USA	1	0%

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

Death1.4%48

Injury12.6%440

Malfunction81%2,831

Other4.3%150

Not given0.7%26

Who filed

Manufacturer report97.7%3,414

Voluntary report0.8%28

User facility report0%0

Distributor report0.3%12

Not given1.2%41

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

Device problems coded

Device problem (FDA code)	Reports	Share
Insufficient device problem information	378	10.8%
Battery problema problem with the battery	347	9.9%
Pumping stopped	288	8.2%
Power problem	230	6.6%
Device alarm system	229	6.6%
Infusion or flow problema problem with flow or infusion	191	5.5%
Electrical /electronic property probleman electrical or electronic problem	156	4.5%
Other (for use when an appropriate device code cannot be identified)	149	4.3%
Mechanical problema mechanical problem	142	4.1%
No display/image	124	3.5%
Unexpected shutdown	123	3.5%
Display or visual feedback problem	117	3.3%
Noise, audible	115	3.3%
Pumping problem	110	3.1%
Device displays incorrect message	98	2.8%
Device operates differently than expectedthe device behaved unexpectedly	73	2.1%
Communication or transmission problemthe device could not communicate or transmit	68	1.9%
Decreased pump speed	67	1.9%
Overheating of device	66	1.9%
Breakthe device broke	47	1.3%

Questions about control, pump speed, cardiopulmonary bypass reports

What is product code DWA?

FDA's classification code for "Control, pump speed, cardiopulmonary bypass", class 2, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.

How many reports carry this code?

3,495 reports through August 2026, 342 of them in the latest 12 months.

Which brands appear most often?

CentriMag 2nd Generation Primary Console (667), Bio Console 560 (590), Terumo Centrifugal System (317), Centrifugal Pump 5 Cp5 (186) and Centrifugal Pump System With Tubing Clamp (165). 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.