Dialyzer, high permeability with or without sealed dialysate system: medical device reports filed with FDA

43,764 reports carry this product code, 1992–2026; 30 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.

43,764
reports with this product code: 0.2% of all MAUDE reports; 2,742
reports, 12 months to August 2026: 2,525 in the 12 months before; 64.6%
classified as malfunction: 62.3% across all reports; 5.9%
classified as death, as reported: 0.9% across all reports

Product code KDI is FDA's classification for "Dialyzer, high permeability with or without sealed dialysate system" (gastroenterology, Urology panel), a class 2 device. 43,764 medical device reports carry this product code, 0.2% of the MAUDE database, from June 1992 to August 2026.

2,742 reports arrived in the 12 months to August 2026, close to the 2,525 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 (64.6%), injury (27.9%) and death (5.9%). 30 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
MiniCap	9,126	409	1.1%	75%
NxStage System One	2,949	120	5.7%	21.2%
Optiflux 180nre Dialyzer Finished Assy	2,145	69	0.6%	85.3%
Optiflux 160nre Dialyzer Finished Assy	1,904	27	0.8%	87.5%
Fresenius 2008k	1,741	0	76.8%	0.3%
Prismaflex Sets (St)	1,364	466	0.4%	98.5%
2008T HEMODIALYSIS SYS., with CDX	1,136	31	4.8%	85.9%
2008k2 Hemodialysis Sys Olc/Diasafe Pls	927	3	3.9%	90.3%
Prismaflex Sets (M)	917	287	0.1%	99.5%
OPTIFLUX F180NRe HF 12/CS 1.7SA EBEAM	800	286	0.1%	97.8%
Prismaflex	471	4	7.7%	56.9%
OPTIFLUX F160NRe HF 12/CS 1.5SA EBEAM	466	203	0%	98.1%
2008t Hd Sys Cdx W/Bibag Blue Star	460	51	2.6%	93.3%
Prismaflex M150	442	0	0.7%	87.8%
Mini-Cap Disconnect W/Pvp-1solution	432	0	3.5%	12.1%
2008t Hemodialysis System W/Bibag	421	31	4%	90.5%
Mini-Cap	406	0	0.2%	22.4%
Psn Dialyzer Psn 210	362	0	0.8%	76.4%
AK 96 Machines	323	94	0.3%	84.8%
Polyflux 140h	299	0	0%	92%
Prismaflex M100 Set	292	0	1%	77.1%
Polyflux	282	116	0.3%	79.9%
Revaclear	281	19	1.1%	72.8%
2008k Hemodialysis Sys Olc/Diasafe Plus	276	0	5.4%	87.5%
2008t Hd Sys W/O Cdx W/Bibag Blue Star	270	24	2.6%	93.7%
Prisma Control Unit	269	0	6%	56%
Optiflux F250nre Dialyzer	241	0	0.4%	93.8%
Phoenix	241	16	5.5%	32.9%
Polyflux L Capillary Dialyzer	229	0	1.3%	60.6%
Meridian Hemodialysis Machine	228	0	7.6%	60.6%

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
Baxter Healthcare - Cleveland	8,088	18.5%
Baxter Healthcare	6,566	15%
Ogden Manufacturing Plant	5,964	13.6%
Fresenius Medical Care North America	3,327	7.6%
Nxstage Medical	3,242	7.4%
Concord Manufacturing	2,895	6.6%
Vantive US Healthcare	1,764	4%
Baxter Healthcare - Swinford	1,197	2.7%
Baxter Healthcare - Guangzhou	787	1.8%
Fresenius USA	676	1.5%
Erika De Reynosa De C V	475	1.1%
Gambro Dialysatoren	430	1%
Baxter Healthcare - Cali	264	0.6%
Baxter Healthcare - Largo	95	0.2%
B Braun Medical	79	0.2%

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

Death5.9%2,589

Injury27.9%12,228

Malfunction64.6%28,264

Other1.3%584

Not given0.2%99

Who filed

Manufacturer report94.4%41,301

Voluntary report1.2%515

User facility report0%0

Distributor report2.2%946

Not given2.3%1,002

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

Device problems coded

Device problem (FDA code)	Reports	Share
Fluid/blood leak	13,975	31.9%
Insufficient device problem information	4,142	9.5%
Product quality problem	2,723	6.2%
Device operates differently than expectedthe device behaved unexpectedly	1,954	4.5%
Leak/splashthe device leaked	1,679	3.8%
Thermal decomposition of device	1,417	3.2%
Alarm, audible	1,240	2.8%
Mechanical problema mechanical problem	1,160	2.7%
Reflux within device	1,134	2.6%
Detachment of device component	1,099	2.5%
Breakthe device broke	1,086	2.5%
Crackthe device cracked	1,048	2.4%
Improper or incorrect procedure or method	937	2.1%
Inadequate ultra filtration	830	1.9%
Contamination	590	1.3%
Replace	571	1.3%
Device contamination with chemical or other material	512	1.2%
Component missing	502	1.1%
Device displays incorrect message	468	1.1%
Air leak	448	1%

Questions about dialyzer, high permeability with or without sealed dialysate system reports

What is product code KDI?

FDA's classification code for "Dialyzer, high permeability with or without sealed dialysate system", class 2, reviewed by the gastroenterology, Urology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

43,764 reports through August 2026, 2,742 of them in the latest 12 months.

Which brands appear most often?

MiniCap (9,126), NxStage System One (2,949), Optiflux 180nre Dialyzer Finished Assy (2,145), Optiflux 160nre Dialyzer Finished Assy (1,904) and Fresenius 2008k (1,741). 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.