Device manufacturer, as written on reports

Fresenius Medical Care North America: medical device reports filed with FDA

37,664 reports name it as the manufacturer of the device involved, 1997–2026.

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.

37,664
reports naming it as manufacturer: 0.1% of all MAUDE reports; 9
reports, 12 months to August 2026: 16 in the 12 months before; 10.7%
classified as malfunction: 62.3% across all reports; 65.5%
classified as death, as reported: 0.9% across all reports

37,664 medical device reports received by FDA give Fresenius Medical Care North America as the manufacturer of the device involved, 0.1% of the MAUDE database, from July 1997 to March 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

9 reports arrived in the 12 months to August 2026, down 44% from 16 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 death (65.5%), injury (23.4%) and malfunction (10.7%). 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
Granuflo	Dialysate concentrate for hemodialysis (liquid or powder)	13,772	0	82.1%
Naturalyte	Dialysate concentrate for hemodialysis (liquid or powder)	13,683	0	82.2%
Liberty Cycler	System, peritoneal, automatic delivery	2,506	0	9%
Fresenius 2008k	Dialyzer, high permeability with or without sealed dialysate system	1,459	0	76.8%
Optiflux 180nre Dialyzer Finished Assy	Dialyzer, high permeability with or without sealed dialysate system	798	69	0.6%
Crit-Line Blood Chamber	Accessories, blood circuit, hemodialysis	571	0	0%
Optiflux 160nre Dialyzer Finished Assy	Dialyzer, high permeability with or without sealed dialysate system	554	27	0.8%
2008k2 Hemodialysis Sys Olc/Diasafe Pls	Dialyzer, high permeability with or without sealed dialysate system	547	3	3.9%
Liberty Cycler Set Single Conn /Ext Dl	System, peritoneal, automatic delivery	220	952	0.5%
Liberty Cycler Set Dual Patient Connect	System, peritoneal, automatic delivery	217	150	0.8%
2008T HEMODIALYSIS SYS., with CDX	Dialyzer, high permeability with or without sealed dialysate system	208	31	4.8%
2008k Hemodialysis Sys Olc/Diasafe Plus	Dialyzer, high permeability with or without sealed dialysate system	184	0	5.4%
Fresenius Liberty Cycler	System, peritoneal, automatic delivery	182	0	9.9%
Fresenius Dialysis Delivery System	System, dialysate delivery, sealed	130	0	11%
Optiflux 200nre Dialyzer Finished Assy	Dialyzer, high permeability with or without sealed dialysate system	75	5	0.5%
Custom Combi Set	Set, tubing, blood, with and without anti-regurgitation valve	50	15	3.8%
Optiflux F250nre Dialyzer	Dialyzer, high permeability with or without sealed dialysate system	40	0	0.4%
Liberty Cycler Set	System, peritoneal, automatic delivery	37	0	4.3%
Fresenius	Dialyzer, high permeability with or without sealed dialysate system	31	0	6.1%
2008t Hemodialysis System W/Bibag	Dialyzer, high permeability with or without sealed dialysate system	30	31	4%
Liberty Cycler Set Single Patient Conn	System, peritoneal, automatic delivery	9	26	0.9%
Dialyzer	Dialyzer, high permeability with or without sealed dialysate system	1	69	2.2%

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
KPO	Dialysate concentrate for hemodialysis (liquid or powder)	28,059	74.5%
FKX	System, peritoneal, automatic delivery	3,523	9.4%
KDI	Dialyzer, high permeability with or without sealed dialysate system	3,327	8.8%
FJI	Dialyzer, capillary, hollow fiber	1,669	4.4%
KOC	Accessories, blood circuit, hemodialysis	614	1.6%
FJK	Set, tubing, blood, with and without anti-regurgitation valve	241	0.6%
FII	System, dialysate delivery, sealed	115	0.3%
KDJ	Set, administration, for peritoneal dialysis, disposable	44	0.1%
FKP	System, dialysate delivery, single patient	4	0%
CAC	Apparatus, autotransfusion	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

Death65.5%24,686

Injury23.4%8,796

Malfunction10.7%4,033

Other0.3%101

Not given0.1%48

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

Questions about Fresenius Medical Care North America reports

How many FDA device reports name Fresenius Medical Care North America as manufacturer?

37,664 reports through August 2026, 9 of them in the latest 12 months.

Which of its brands appear most often?

Granuflo (13,772), Naturalyte (13,683), Liberty Cycler (2,506), Fresenius 2008k (1,459) and Optiflux 180nre Dialyzer Finished Assy (798).

Which device types does it report on?

dialysate concentrate for hemodialysis (liquid or powder) (74.5%), system, peritoneal, automatic delivery (9.4%), dialyzer, high permeability with or without sealed dialysate system (8.8%) and dialyzer, capillary, hollow fiber (4.4%).

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.