System, dialysate delivery, sealed: medical device reports filed with FDA

3,214 reports carry this product code, 1993–2014; 15 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.

3,214
reports with this product code: 0% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 62.1%
classified as malfunction: 62.3% across all reports; 4.6%
classified as death, as reported: 0.9% across all reports

Product code FII is FDA's classification for "System, dialysate delivery, sealed" (gastroenterology, Urology panel), a class 2 device. 3,214 medical device reports carry this product code, 0% of the MAUDE database, from January 1993 to April 2014.

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 (62.1%), injury (20.7%) and other (11.3%). 15 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
Cobe Centrysystem 3	1,047	0	0.8%	83.3%
Prisma Control Unit	292	0	6%	56%
Fresenius Dialysis Delivery System	241	0	11%	60.4%
Phoenix	216	16	5.5%	32.9%
Prismaflex System	184	0	1.8%	76.1%
NxStage System One	99	120	5.7%	21.2%
Fresenius	69	0	6.1%	13.7%
System 1000 Spds	50	0	3.1%	75.1%
1550 Hemodialysis Machine	29	0	10.6%	53.3%
Meridian Hemodialysis Machine	8	0	7.6%	60.6%
Prismaflex	8	4	7.7%	56.9%
Fresenius 2008k	3	0	76.8%	0.3%
Fusa F80b Hf/Ps/1 8/H	2	0	0%	13.7%
Optiflux 200nre Dialyzer Finished Assy	2	5	0.5%	92%
B Braun	1	12	3%	77.8%

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
Gambro Healthcare	1,029	32%
Fresenius USA	201	6.3%
Fresenius Medical Care North America	115	3.6%
Nxstage Medical	99	3.1%
Baxter Healthcare	33	1%
B Braun Medical	6	0.2%
Medcomp	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

Death4.6%149

Injury20.7%666

Malfunction62.1%1,997

Other11.3%362

Not given1.2%40

Who filed

Manufacturer report75.9%2,441

Voluntary report4.3%137

User facility report0%0

Distributor report9.8%314

Not given10%322

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

Device problems coded

Device problem (FDA code)	Reports	Share
Device issuea problem with the device	325	10.1%
Replace	255	7.9%
Alarm, audible	253	7.9%
Device alarm system	244	7.6%
Other (for use when an appropriate device code cannot be identified)	241	7.5%
Output, high	170	5.3%
Leak/splashthe device leaked	149	4.6%
Repair	129	4%
Air leak	117	3.6%
Fluid/blood leak	106	3.3%
Device displays incorrect message	96	3%
Insufficient flow or under infusion	77	2.4%
Normal	75	2.3%
Output, low	73	2.3%
Bubble(s)	67	2.1%
Excess flow or over-infusion	59	1.8%
Inadequate ultra filtration	57	1.8%
Disconnection	55	1.7%
Dislodged	45	1.4%
Inaccurate delivery	44	1.4%

Questions about system, dialysate delivery, sealed reports

What is product code FII?

FDA's classification code for "System, dialysate delivery, sealed", 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?

3,214 reports through August 2026, 0 of them in the latest 12 months.

Which brands appear most often?

Cobe Centrysystem 3 (1,047), Prisma Control Unit (292), Fresenius Dialysis Delivery System (241), Phoenix (216) and Prismaflex System (184). 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.