Dialysate concentrate for hemodialysis (liquid or powder): medical device reports filed with FDA

30,009 reports carry this product code, 1992–2026; 9 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.

30,009
reports with this product code: 0.1% of all MAUDE reports; 125
reports, 12 months to August 2026: 103 in the 12 months before; 5%
classified as malfunction: 62.3% across all reports; 76.9%
classified as death, as reported: 0.9% across all reports

Product code KPO is FDA's classification for "Dialysate concentrate for hemodialysis (liquid or powder)" (gastroenterology, Urology panel), a class 2 device. 30,009 medical device reports carry this product code, 0.1% of the MAUDE database, from June 1992 to August 2026.

125 reports arrived in the 12 months to August 2026, up 21% from 103 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 (76.9%), injury (17.8%) and malfunction (5%). 9 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
Granuflo	13,856	0	82.1%	0%
Naturalyte	13,746	0	82.2%	0%
NxStage System One	238	120	5.7%	21.2%
Accusol	236	0	0%	99.6%
Fresenius 2008k	12	0	76.8%	0.3%
B Braun	2	12	3%	77.8%
Fresenius	2	0	6.1%	13.7%
Dialyzer	1	69	2.2%	57.4%
Tandem T Slim Insulin Delivery System	1	0	0.1%	65.2%

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
Fresenius Medical Care North America	28,059	93.5%
Nxstage Medical	331	1.1%
Concord Manufacturing	258	0.9%
Erika De Reynosa De C V	28	0.1%
Baxter Healthcare - Cali	16	0.1%
Gambro Healthcare	14	0%
Fresenius USA	9	0%
Baxter Hlthcare	1	0%
Ogden Manufacturing Plant	1	0%
Vantive US Healthcare	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

Death76.9%23,081

Injury17.8%5,346

Malfunction5%1,490

Other0.1%40

Not given0.2%52

Who filed

Manufacturer report98.9%29,692

Voluntary report0.7%210

User facility report0%0

Distributor report0%13

Not given0.3%94

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

Device problems coded

Device problem (FDA code)	Reports	Share
Insufficient device problem information	27,821	92.7%
Breakthe device broke	310	1%
Leak/splashthe device leaked	270	0.9%
Fluid/blood leak	243	0.8%
Chemical problem	210	0.7%
Thermal decomposition of device	179	0.6%
Precipitate in device or device ingredient	152	0.5%
Smoking	99	0.3%
Material separation	49	0.2%
Melted	47	0.2%
Device contaminated during manufacture or shipping	43	0.1%
Device operates differently than expectedthe device behaved unexpectedly	35	0.1%
Defective component	31	0.1%
Detachment of device or device componentpart of the device came off	29	0.1%
Fire	28	0.1%
Sparking	26	0.1%
Improper or incorrect procedure or method	25	0.1%
Detachment of device component	24	0.1%
Material discolored	23	0.1%
Contamination	22	0.1%

Questions about dialysate concentrate for hemodialysis (liquid or powder) reports

What is product code KPO?

FDA's classification code for "Dialysate concentrate for hemodialysis (liquid or powder)", 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?

30,009 reports through August 2026, 125 of them in the latest 12 months.

Which brands appear most often?

Granuflo (13,856), Naturalyte (13,746), NxStage System One (238), Accusol (236) and Fresenius 2008k (12). 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.