System, peritoneal, automatic delivery: medical device reports filed with FDA

164,765 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.

164,765
reports with this product code: 0.6% of all MAUDE reports; 3,076
reports, 12 months to August 2026: 3,212 in the 12 months before; 85.8%
classified as malfunction: 62.3% across all reports; 2.1%
classified as death, as reported: 0.9% across all reports

Product code FKX is FDA's classification for "System, peritoneal, automatic delivery" (gastroenterology, Urology panel), a class 2 device. 164,765 medical device reports carry this product code, 0.6% of the MAUDE database, from September 1992 to August 2026.

3,076 reports arrived in the 12 months to August 2026, close to the 3,212 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 (85.8%), injury (11.9%) and death (2.1%). 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
HomeChoice Automated PD Set with Cassette	27,332	149	0.5%	87%
Homechoice	25,664	0	2.4%	95.8%
Homechoice Pro	22,607	0	3.6%	93.4%
Liberty Select Cycler Assy Non-Valuated	15,784	1,174	3.6%	75.4%
Liberty Cycler Set Single Conn /Ext Dl	11,531	952	0.5%	68.1%
Liberty Cycler	3,739	0	9%	22.2%
Ni	3,477	1,587	1.8%	29.5%
Homechoice Automated Pd Set W/Cassette 4-Prong	3,258	0	0.2%	92.9%
Liberty Cycler Set Dual Patient Connect	3,082	150	0.8%	70.5%
Automated Pd Set W/Cassette4 Prong	2,076	0	0.3%	87%
Amia Automated Pd Cycler Set	1,668	0	0%	98.5%
Integrated Apd Set W/Cassette3-Prong	1,624	0	0.4%	85.7%
Homechoice Cycler-Refurbished	1,608	0	1.2%	95.4%
Fmc Cassette	1,092	30	1%	23.2%
Homechoice Automated Pd Set W/Cassette 4 Prong	896	0	0.1%	94.8%
Ul Liberty Cycler Assembly Non-Valuated	726	1	5.8%	52.5%
Pd Cycler 110 Volt Home Choicepro Automated	675	0	1.3%	96.6%
Liberty Select Cycler	586	0	4.8%	67.6%
Homechoice Integrated Apd Set With Cassette 3-Prong	557	0	0%	88.7%
Liberty Cycler Ul	540	0	2%	16.7%
Liberty Cycler Set Single Patient Conn	451	26	0.9%	65.8%
Homechoice Low Recirculation Volume Apd Set With Cassette	436	2	0.9%	82.8%
Integrated Apd Set W/Cassette3 Prong	410	0	0.2%	93.9%
Intergrated Apd Set	315	128	0%	99.4%
Amia Automated PD Set with Cassette	268	78	0%	99.6%
Homechoice Automated Pd System 115 Volt	256	0	4.3%	51.9%
Renal - Disposable	242	0	1.4%	12.3%
Homechoice Automated Pd System 115 Volt Refurbished	233	0	9.4%	56.7%
Liberty Cycler Set	230	0	4.3%	52.8%
Homechoice Apd Set	192	107	0%	98.4%

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 - Mountain Home	41,656	25.3%
Baxter Healthcare - Largo	38,033	23.1%
Baxter Healthcare	28,270	17.2%
Concord Manufacturing	16,532	10%
Erika De Reynosa De C V	16,308	9.9%
Baxter Healthcare - Singapore	14,171	8.6%
Fresenius Medical Care North America	3,523	2.1%
Reynosa Manufacturing	1,329	0.8%
Vantive US Healthcare	1,163	0.7%
Baxter Healthcare Pte	403	0.2%
Baxter International	325	0.2%
Baxter Healthcare - Cali	77	0%
Baxter Healthcare - Cleveland	27	0%
Baxter Healthcare - Swinford	15	0%
Fresenius USA	11	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

Death2.1%3,441

Injury11.9%19,660

Malfunction85.8%141,317

Other0.1%194

Not given0.1%153

Who filed

Manufacturer report99.4%163,812

Voluntary report0.1%146

User facility report0%0

Distributor report0.5%768

Not given0%39

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

Device problems coded

Device problem (FDA code)	Reports	Share
Device displays incorrect message	46,876	28.5%
Overfill	31,267	19%
Fluid/blood leak	24,517	14.9%
Improper or incorrect procedure or method	12,503	7.6%
Device operates differently than expectedthe device behaved unexpectedly	12,287	7.5%
Air leak	8,941	5.4%
Thermal decomposition of device	5,004	3%
Disconnection	3,904	2.4%
Insufficient device problem information	2,933	1.8%
Leak/splashthe device leaked	1,896	1.2%
Protective measures problem	1,422	0.9%
Loose or intermittent connection	1,421	0.9%
Replace	1,050	0.6%
Contamination	789	0.5%
Failure to prime	745	0.5%
Device contamination with chemical or other material	698	0.4%
Volume accuracy problem	685	0.4%
Detachment of device component	660	0.4%
Connection problema connection problem	630	0.4%
Hole in material	622	0.4%

Questions about system, peritoneal, automatic delivery reports

What is product code FKX?

FDA's classification code for "System, peritoneal, automatic delivery", 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?

164,765 reports through August 2026, 3,076 of them in the latest 12 months.

Which brands appear most often?

HomeChoice Automated PD Set with Cassette (27,332), Homechoice (25,664), Homechoice Pro (22,607), Liberty Select Cycler Assy Non-Valuated (15,784) and Liberty Cycler Set Single Conn /Ext Dl (11,531). 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.