Devices › System, peritoneal, automatic delivery
Device brand name · System peritoneal automatic delivery
Automated Pd Set W/Cassette4 Prong: medical device reports filed with FDA
2,090 reports name it, 2008–2013. Manufacturer given most often on reports: Baxter Healthcare - Mountain Home. Product code FKX.
- 2,090
- device reports naming the brand
- 0% of all MAUDE reports · about 114 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 87%
- classified as malfunction
- 85.8% across the product code
- 0.3%
- classified as death, as reported
- 7 reports · not verified by FDA
FDA's MAUDE database holds 2,090 reports that name the brand "Automated Pd Set W/Cassette4 Prong" (system peritoneal automatic delivery), received between February 2008 and October 2013; the manufacturer given most often on reports is Baxter Healthcare - Mountain Home. Spellings of one product vary from report to report.
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 (87%), injury (12.2%) and death (0.3%); 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 device displays incorrect message (41.2%), air leak (27.5%) and improper or incorrect procedure or method (14.1%). The patient problems coded most often are peritonitis, bacterial infection and abdominal pain. 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 Automated Pd Set W/Cassette4 Prong was received in the five years to August 2026; the latest was received in October 2013.
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 |
|---|---|---|---|
| Device displays incorrect message | 862 | 41.2% | 28.5% |
| Air leak | 575 | 27.5% | 5.4% |
| Improper or incorrect procedure or method | 294 | 14.1% | 7.6% |
| Disconnection | 166 | 7.9% | 2.4% |
| Fluid/blood leak | 158 | 7.6% | 14.9% |
| Component falling | 150 | 7.2% | 0.3% |
| Detachment of device component | 148 | 7.1% | 0.4% |
| Insufficient device problem information | 104 | 5% | 1.8% |
| Contamination | 45 | 2.2% | 0.5% |
| Alarm, audible | 41 | 2% | 0.3% |
| Hole in material | 31 | 1.5% | 0.4% |
| Crackthe device cracked | 30 | 1.4% | 0.3% |
| Material puncture/hole | 23 | 1.1% | 0.2% |
| Breakthe device broke | 21 | 1% | 0.3% |
| Inadequate or insufficient training | 17 | 0.8% | 0.1% |
| Device alarm system | 15 | 0.7% | 0.3% |
| Connection problema connection problem | 14 | 0.7% | 0.4% |
| Failure to prime | 13 | 0.6% | 0.5% |
| Human-device interface problem | 13 | 0.6% | 0% |
| Leak/splashthe device leaked | 11 | 0.5% | 1.2% |
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 |
|---|---|---|
| Peritonitis | 246 | 11.8% |
| Bacterial infectiona bacterial infection | 102 | 4.9% |
| Abdominal painstomach or belly pain | 41 | 2% |
| Treatment with medication(s) | 32 | 1.5% |
| Hospitalization required | 28 | 1.3% |
| Therapy/non-surgical treatment, additional | 21 | 1% |
| Deaththe patient died; cause not stated by this term | 20 | 1% |
| Fungal infectiona fungal infection | 13 | 0.6% |
| Painpain, site not specified | 12 | 0.6% |
| Staphylococcus aureus | 11 | 0.5% |
| No patient involvement | 9 | 0.4% |
| Nauseafeeling sick | 8 | 0.4% |
| Improved patient condition | 7 | 0.3% |
| Therapy/non-surgical treatment, aborted/stopped | 7 | 0.3% |
| Chillschills or shivering | 4 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Automated Pd Set W/Cassette4 Prong | Product code FKX | All MAUDE reports |
|---|---|---|---|
| Reports | 2,090 | 164,765 | 26,136,888 |
| Share of that pool | — | 1.3% | 0% |
| Classified as death, per 1,000 reports | 3 | 21 | 9 |
| Classified as injury | 12.2% | 11.9% | 36.2% |
| Classified as malfunction | 87% | 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% |
| 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% |
| 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 Automated Pd Set W/Cassette4 Prong reports
How many FDA reports name Automated Pd Set W/Cassette4 Prong?
2,090 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 (87%), injury (12.2%) and death (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device displays incorrect message (41.2%), air leak (27.5%), improper or incorrect procedure or method (14.1%), disconnection (7.9%) and fluid/blood leak (7.6%). 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 Automated Pd Set W/Cassette4 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.