Devices › System, peritoneal, automatic delivery

Device brand name · System peritoneal automatic delivery

Home Choice Pro: medical device reports filed with FDA

164 reports name it, 2011–2015. Manufacturer given most often on reports: Baxter Healthcare - Largo. Product code FKX.

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
device reports naming the brand: 0% of all MAUDE reports · about 11 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 89%
classified as malfunction: 85.8% across the product code; 5.5%
classified as death, as reported: 9 reports · not verified by FDA

164 medical device reports received by FDA name the brand "Home Choice Pro" (system peritoneal automatic delivery); the manufacturer given most often on reports is Baxter Healthcare - Largo; received from March 2011 to September 2015. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

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 (89%), death (5.5%) and injury (5.5%); across all system, peritoneal, automatic delivery reports (product code FKX) death is recorded in 2.1% and malfunction in 85.8%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are overfill (62.8%), improper or incorrect procedure or method (9.8%) and device operates differently than expected (9.1%). The patient problems coded most often are death, dyspnea and heart failure. 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."

Reports by month, five years

No report naming Home Choice Pro was received in the five years to August 2026; the latest was received in September 2015.

By year received

Event type and report source

Event type, as classified on the report

Death5.5%9

Injury5.5%9

Malfunction89%146

Other0%0

Not given0%0

Who filed the report

Manufacturer report99.4%163

Voluntary report0.6%1

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 164,765 reports carrying product code FKX. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)	Reports	Share	Share across product code
Overfill	103	62.8%	19%
Improper or incorrect procedure or method	16	9.8%	7.6%
Device operates differently than expectedthe device behaved unexpectedly	15	9.1%	7.5%
Device displays incorrect message	9	5.5%	28.5%
Grounding malfunction	1	0.6%	0.3%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)	Reports	Share
Deaththe patient died; cause not stated by this term	5	3%
Dyspneashortness of breath	1	0.6%
Heart failure	1	0.6%
No patient involvement	1	0.6%
Renal failurekidney failure	1	0.6%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	Home Choice Pro	Product code FKX	All MAUDE reports
Reports	164	164,765	26,136,888
Share of that pool	—	0.1%	0%
Classified as death, per 1,000 reports	55	21	9
Classified as injury	5.5%	11.9%	36.2%
Classified as malfunction	89%	85.8%	62.3%
Filed by the manufacturer	99.4%	99.4%	94.9%

Shares are of reports, not 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."

Other brands with product code FKX

Brand	Reports	Latest 12 months	Classified as death
HomeChoice Automated PD Set with Cassette	27,417	149	0.5%
Homechoice	25,675	0	2.4%
Homechoice Pro	22,614	0	3.6%
Liberty Select Cycler Assy Non-Valuated	15,784	1,174	3.6%
Liberty Cycler Set Single Conn /Ext Dl	11,729	952	0.5%
Liberty Cycler	3,742	0	9%
Ni	32,939	1,587	1.8%
Homechoice Automated Pd Set W/Cassette 4-Prong	3,262	0	0.2%
Liberty Cycler Set Dual Patient Connect	3,083	150	0.8%
Automated Pd Set W/Cassette4 Prong	2,090	0	0.3%
Amia Automated Pd Cycler Set	1,671	0	0%
Integrated Apd Set W/Cassette3-Prong	1,641	0	0.4%
Homechoice Cycler-Refurbished	1,613	0	1.2%
Fmc Cassette	1,093	30	1%
Homechoice Automated Pd Set W/Cassette 4 Prong	906	0	0.1%

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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Home Choice Pro reports

How many FDA reports name Home Choice Pro?

164 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

malfunction (89%), death (5.5%) and injury (5.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

overfill (62.8%), improper or incorrect procedure or method (9.8%), device operates differently than expected (9.1%), device displays incorrect message (5.5%) and grounding malfunction (0.6%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (99.4%) and voluntary reports (0.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Home Choice Pro was at fault?

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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.