Device manufacturer, as written on reports

Sorin Group Deutschland: medical device reports filed with FDA

3,141 reports name it as the manufacturer of the device involved, 2005–2017.

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.

3,141
reports naming it as manufacturer: 0% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 43.5%
classified as malfunction: 62.3% across all reports; 1.4%
classified as death, as reported: 0.9% across all reports

3,141 medical device reports received by FDA give Sorin Group Deutschland as the manufacturer of the device involved, 0% of the MAUDE database, from February 2005 to October 2017. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

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 (43.5%), other (36.6%) and injury (3.1%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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 named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
S5 Roller Pump	Console, heart-lung machine, cardiopulmonary bypass	746	0	0.6%
Sorin Heater-Cooler System 3t	Controller, temperature, cardiopulmonary bypass	506	0	2.2%
S5 Double Head Pump	Pump, blood, cardiopulmonary bypass, roller type	203	0	0%
S3 Roller Pump	Console, heart-lung machine, cardiopulmonary bypass	171	0	1.4%
S5 Gas Blender System	Gas control unit, cardiopulmonary bypass	81	0	0%
S5 Mast Roller Pump	Pump, blood, cardiopulmonary bypass, roller type	77	9	0%
Heater-Cooler System 3t	Controller, temperature, cardiopulmonary bypass	28	8	3.5%
S5 System	Console, heart-lung machine, cardiopulmonary bypass	15	2	2%
Centrifugal Pump System With Tubing Clamp	Control, pump speed, cardiopulmonary bypass	7	0	0.6%
Heart Lung Machine	Pump, blood, cardiopulmonary bypass, non-roller type	2	283	3.7%

Brands with a page on this site, 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."

Device types

Product code	Device type	Reports	Share
DTQ	Console, heart-lung machine, cardiopulmonary bypass	1,717	54.7%
DWC	Controller, temperature, cardiopulmonary bypass	594	18.9%
DWB	Pump, blood, cardiopulmonary bypass, roller type	355	11.3%
DWA	Control, pump speed, cardiopulmonary bypass	282	9%
DTX	Gas control unit, cardiopulmonary bypass	94	3%
KFM	Pump, blood, cardiopulmonary bypass, non-roller type	34	1.1%
CAC	Apparatus, autotransfusion	5	0.2%
DTZ	Oxygenator, cardiopulmonary bypass	4	0.1%
DWF	Catheter, cannula and tubing, vascular, cardiopulmonary bypass	1	0%
DXC	Clamp, vascular	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

Death1.4%45

Injury3.1%96

Malfunction43.5%1,365

Other36.6%1,149

Not given15.5%486

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Sorin Group Deutschland reports

How many FDA device reports name Sorin Group Deutschland as manufacturer?

3,141 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

S5 Roller Pump (746), Sorin Heater-Cooler System 3t (506), S5 Double Head Pump (203), S3 Roller Pump (171) and S5 Gas Blender System (81).

Which device types does it report on?

console, heart-lung machine, cardiopulmonary bypass (54.7%), controller, temperature, cardiopulmonary bypass (18.9%), pump, blood, cardiopulmonary bypass, roller type (11.3%) and control, pump speed, cardiopulmonary bypass (9%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."

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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.