Devices › System, peritoneal, automatic delivery
Device brand name · Homechoice cassette
Homechoice Automated Pd Set W/Cassette 4 Prong: medical device reports filed with FDA
906 reports name it, 1997–2006. Manufacturer given most often on reports: Baxter Healthcare. Product code FKX.
- 906
- device reports naming the brand
- 0% of all MAUDE reports · about 31 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 94.8%
- classified as malfunction
- 85.8% across the product code
- 0.1%
- classified as death, as reported
- 1 reports · not verified by FDA
906 medical device reports received by FDA name the brand "Homechoice Automated Pd Set W/Cassette 4 Prong" (homechoice cassette); the manufacturer given most often on reports is Baxter Healthcare; received from March 1997 to July 2006. 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 (94.8%), injury (4.5%) and other (0.6%); 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 leak/splash (20.5%), disconnection (4.1%) and fluid/blood leak (2.6%). The patient problems coded most often are therapy/non-surgical treatment, aborted/stopped, treatment with medication(s) and peritonitis. 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 Homechoice Automated Pd Set W/Cassette 4 Prong was received in the five years to August 2026; the latest was received in July 2006.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
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 |
|---|---|---|---|
| Leak/splashthe device leaked | 186 | 20.5% | 1.2% |
| Disconnection | 37 | 4.1% | 2.4% |
| Fluid/blood leak | 24 | 2.6% | 14.9% |
| Other (for use when an appropriate device code cannot be identified) | 21 | 2.3% | 0.2% |
| Replace | 17 | 1.9% | 0.6% |
| Contamination | 16 | 1.8% | 0.5% |
| Air leak | 11 | 1.2% | 5.4% |
| Tears, rips, holes in device, device material | 7 | 0.8% | 0.1% |
| Failure to prime | 3 | 0.3% | 0.5% |
| Crackthe device cracked | 2 | 0.2% | 0.3% |
| Hole in material | 2 | 0.2% | 0.4% |
| Material separation | 2 | 0.2% | 0.1% |
| Moisture damage | 2 | 0.2% | 0.1% |
| Spillage, accidental | 2 | 0.2% | 0% |
| Tube(s), splitting of | 2 | 0.2% | 0% |
| False alarm | 1 | 0.1% | 0% |
| Improper or incorrect procedure or method | 1 | 0.1% | 7.6% |
| Kinkedthe tube or line kinked | 1 | 0.1% | 0% |
| Loose | 1 | 0.1% | 0% |
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 |
|---|---|---|
| Therapy/non-surgical treatment, aborted/stopped | 70 | 7.7% |
| Treatment with medication(s) | 52 | 5.7% |
| Peritonitis | 33 | 3.6% |
| Hospitalization required | 13 | 1.4% |
| Therapy/non-surgical treatment, additional | 12 | 1.3% |
| Discomfortdiscomfort | 7 | 0.8% |
| Painpain, site not specified | 7 | 0.8% |
| Abdominal painstomach or belly pain | 5 | 0.6% |
| Staphylococcus aureus | 3 | 0.3% |
| Therapy/non-surgical treatment/delayed/prolonged | 3 | 0.3% |
| Bacterial infectiona bacterial infection | 2 | 0.2% |
| Other (for use when an appropriate patient code cannot be identified) | 2 | 0.2% |
| Bleeding | 1 | 0.1% |
| Cramp(s) | 1 | 0.1% |
| Deaththe patient died; cause not stated by this term | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Homechoice Automated Pd Set W/Cassette 4 Prong | Product code FKX | All MAUDE reports |
|---|---|---|---|
| Reports | 906 | 164,765 | 26,136,888 |
| Share of that pool | — | 0.5% | 0% |
| Classified as death, per 1,000 reports | 1 | 21 | 9 |
| Classified as injury | 4.5% | 11.9% | 36.2% |
| Classified as malfunction | 94.8% | 85.8% | 62.3% |
| Filed by the manufacturer | 100% | 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% |
| Ul Liberty Cycler Assembly Non-Valuated | 726 | 1 | 5.8% |
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." 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 Homechoice Automated Pd Set W/Cassette 4 Prong reports
How many FDA reports name Homechoice Automated Pd Set W/Cassette 4 Prong?
906 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 (94.8%), injury (4.5%) and other (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
leak/splash (20.5%), disconnection (4.1%), fluid/blood leak (2.6%), other (for use when an appropriate device code cannot be identified) (2.3%) and replace (1.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Homechoice Automated Pd Set W/Cassette 4 Prong 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.