Devices › System, peritoneal, automatic delivery
Device brand name · System peritoneal automatic delivery
Amia Automated Pd Cycler Set: medical device reports filed with FDA
1,671 reports name it, 2014–2024. Manufacturer given most often on reports: Baxter Healthcare. Product code FKX.
- 1,671
- device reports naming the brand
- 0% of all MAUDE reports · about 139 a year
- 0
- reports, 12 months to August 2026
- 1 in the 12 months before
- 98.5%
- classified as malfunction
- 85.8% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 1,671 reports that name the brand "Amia Automated Pd Cycler Set" (system peritoneal automatic delivery), received between July 2014 and December 2024; the manufacturer given most often on reports is Baxter Healthcare. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, against 1 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 (98.5%) and injury (1.5%); 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 fluid/blood leak (31%), disconnection (22.1%) and detachment of device or device component (12.8%). The patient problems coded most often are no patient involvement, peritonitis and nausea. 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
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
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 |
|---|---|---|---|
| Fluid/blood leak | 518 | 31% | 14.9% |
| Disconnection | 370 | 22.1% | 2.4% |
| Detachment of device or device componentpart of the device came off | 214 | 12.8% | 0.2% |
| Protective measures problem | 169 | 10.1% | 0.9% |
| Loose or intermittent connection | 128 | 7.7% | 0.9% |
| Component missing | 100 | 6% | 0.3% |
| Failure to disconnect | 72 | 4.3% | 0.2% |
| Material puncture/hole | 64 | 3.8% | 0.2% |
| Material split, cut or torn | 63 | 3.8% | 0.2% |
| Improper flow or infusion | 62 | 3.7% | 0.2% |
| Air/gas in device | 60 | 3.6% | 0.2% |
| Device contamination with chemical or other material | 53 | 3.2% | 0.4% |
| Device operates differently than expectedthe device behaved unexpectedly | 48 | 2.9% | 7.5% |
| Breakthe device broke | 40 | 2.4% | 0.3% |
| Device displays incorrect message | 37 | 2.2% | 28.5% |
| Crackthe device cracked | 28 | 1.7% | 0.3% |
| Improper or incorrect procedure or method | 17 | 1% | 7.6% |
| Misassembled | 10 | 0.6% | 0% |
| Fitting problem | 8 | 0.5% | 0.1% |
| Material deformation | 6 | 0.4% | 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 |
|---|---|---|
| No patient involvement | 28 | 1.7% |
| Peritonitis | 19 | 1.1% |
| Nauseafeeling sick | 6 | 0.4% |
| Abdominal painstomach or belly pain | 5 | 0.3% |
| Vomitingbeing sick | 4 | 0.2% |
| Diarrhea | 3 | 0.2% |
| Abdominal cramps | 1 | 0.1% |
| Dyspneashortness of breath | 1 | 0.1% |
| Fever | 1 | 0.1% |
| High blood pressure/ hypertension | 1 | 0.1% |
| Injurya physical injury | 1 | 0.1% |
| Loss of consciousnesspassing out | 1 | 0.1% |
| Sepsisa severe body-wide response to infection | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Amia Automated Pd Cycler Set | Product code FKX | All MAUDE reports |
|---|---|---|---|
| Reports | 1,671 | 164,765 | 26,136,888 |
| Share of that pool | — | 1% | 0% |
| Classified as death, per 1,000 reports | 0 | 21 | 9 |
| Classified as injury | 1.5% | 11.9% | 36.2% |
| Classified as malfunction | 98.5% | 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% |
| 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 Amia Automated Pd Cycler Set reports
How many FDA reports name Amia Automated Pd Cycler Set?
1,671 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 (98.5%) and injury (1.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
fluid/blood leak (31%), disconnection (22.1%), detachment of device or device component (12.8%), protective measures problem (10.1%) and loose or intermittent connection (7.7%). 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 Amia Automated Pd Cycler Set 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.