Device manufacturer, as written on reports

Baxter Healthcare - Mountain Home: medical device reports filed with FDA

53,010 reports name it as the manufacturer of the device involved, 2008–2020.

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.

53,010
reports naming it as manufacturer: 0.2% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 82%
classified as malfunction: 62.3% across all reports; 0.7%
classified as death, as reported: 0.9% across all reports

53,010 medical device reports received by FDA give Baxter Healthcare - Mountain Home as the manufacturer of the device involved, 0.2% of the MAUDE database, from February 2008 to March 2020. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

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 (82%), injury (17.1%) and death (0.7%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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 named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
HomeChoice Automated PD Set with Cassette	System, peritoneal, automatic delivery	22,612	149	0.5%
MiniCap Transfer Set	Set, administration, for peritoneal dialysis, disposable	5,778	168	1.1%
Automated Pd Set W/Cassette4 Prong	System, peritoneal, automatic delivery	1,989	0	0.3%
Integrated Apd Set W/Cassette3-Prong	System, peritoneal, automatic delivery	1,613	0	0.4%
Ni	Set, administration, for peritoneal dialysis, disposable	1,356	1,587	1.8%
Uv Flash Transfer Sets	Set, administration, for peritoneal dialysis, disposable	1,025	0	0%
Extension Set	Set, administration, for peritoneal dialysis, disposable	950	66	1.3%
Capd Disconnect Y Set	Set, administration, for peritoneal dialysis, disposable	510	0	1.6%
Minicap Extend Life Pd Transfset W/Twist Clamp	Set, administration, for peritoneal dialysis, disposable	452	0	0.3%
Amia Automated Pd Cycler Set	System, peritoneal, automatic delivery	408	0	0%
Integrated Apd Set W/Cassette3 Prong	System, peritoneal, automatic delivery	405	0	0.2%
Homechoice Low Recirculation Volume Apd Set With Cassette	System, peritoneal, automatic delivery	284	2	0.9%
Uv-Flash Solution Transfer Set Short - Japan	Set, administration, for peritoneal dialysis, disposable	248	0	0%
Titanium Transfer Set	Set, administration, for peritoneal dialysis, disposable	148	1	0%
Renal - Disposable	Set, administration, for peritoneal dialysis, disposable	68	0	1.4%
MiniCap	Dialyzer, high permeability with or without sealed dialysate system	29	409	1.1%
Homechoice	System, peritoneal, automatic delivery	19	0	2.4%
Access	Set, administration, intravascular	4	0	0%
Locking Titanium Adapter	Set, administration, for peritoneal dialysis, disposable	4	5	1%
Mini-Cap Disconnect W/Pvp-1solution	Dialyzer, high permeability with or without sealed dialysate system	4	0	3.5%
Homechoice Pro	System, peritoneal, automatic delivery	2	0	3.6%
Connection Shield	Set, administration, for peritoneal dialysis, disposable	1	0	0%
Flexicap	Set, administration, for peritoneal dialysis, disposable	1	0	1.9%
Ivt Disposable	Container, i.v.	1	0	0%
Mini-Cap	Dialyzer, high permeability with or without sealed dialysate system	1	0	0.2%

Brands with a page on this site, 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."

Device types

Product code	Device type	Reports	Share
FKX	System, peritoneal, automatic delivery	41,656	78.6%
KDJ	Set, administration, for peritoneal dialysis, disposable	11,205	21.1%
KSR	Container, empty, for collection & processing of blood & blood components	66	0.1%
KDI	Dialyzer, high permeability with or without sealed dialysate system	54	0.1%
FRN	Pump, infusion	14	0%
KSE	Refrigerator, freezer, blood storage	4	0%
FPA	Set, administration, intravascular	2	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

Death0.7%392

Injury17.1%9,070

Malfunction82%43,483

Other0%0

Not given0.1%65

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Baxter Healthcare - Mountain Home reports

How many FDA device reports name Baxter Healthcare - Mountain Home as manufacturer?

53,010 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

HomeChoice Automated PD Set with Cassette (22,612), MiniCap Transfer Set (5,778), Automated Pd Set W/Cassette4 Prong (1,989), Integrated Apd Set W/Cassette3-Prong (1,613) and Ni (1,356).

Which device types does it report on?

system, peritoneal, automatic delivery (78.6%), set, administration, for peritoneal dialysis, disposable (21.1%), container, empty, for collection & processing of blood & blood components (0.1%) and dialyzer, high permeability with or without sealed dialysate system (0.1%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."

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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.