Device manufacturer, as written on reports

Baxter Healthcare: medical device reports filed with FDA

279,141 reports name it as the manufacturer of the device involved, 1992–2026.

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.

279,141
reports naming it as manufacturer: 1.1% of all MAUDE reports; 11,947
reports, 12 months to August 2026: 13,055 in the 12 months before; 83%
classified as malfunction: 62.3% across all reports; 1.1%
classified as death, as reported: 0.9% across all reports

279,141 medical device reports received by FDA give Baxter Healthcare as the manufacturer of the device involved, 1.1% of the MAUDE database, from January 1992 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

11,947 reports arrived in the 12 months to August 2026, close to the 13,055 of 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 (83%), injury (15.5%) and death (1.1%). 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
Spectrum Infusion Pump	Pump, infusion	127,007	15	0%
Ni	Set, administration, for peritoneal dialysis, disposable	22,648	1,587	1.8%
Spectrum Iq Infusion Pump	Pump, infusion	5,908	0	0.2%
Infusor	Pump, infusion, elastomeric	4,854	620	0%
FOLFusor	Pump, infusion, elastomeric	4,222	525	0%
MiniCap Transfer Set	Set, administration, for peritoneal dialysis, disposable	3,973	168	1.1%
Spectrum IQ	Pump, infusion	3,180	1,719	0.1%
Access	Set, administration, intravascular	3,109	0	0%
Homechoice Automated Pd Set W/Cassette 4-Prong	System, peritoneal, automatic delivery	3,104	0	0.2%
HomeChoice Automated PD Set with Cassette	System, peritoneal, automatic delivery	2,825	149	0.5%
Novum IQ	Pump, infusion	2,302	809	0.2%
Exactamix	Set, i.v. fluid transfer	2,292	811	0%
SIGMA Spectrum Infusion Pump	Pump, infusion	2,266	1,128	0.2%
Minicap Pd Transfer Set Easy-Lock With Twist Clamp	Set, administration, for peritoneal dialysis, disposable	1,575	0	0.1%
Centrella Bed	Bed, ac-powered adjustable hospital	1,327	798	0.2%
Exactamix Tubing Sets For Baxa Exacta-Med Pharmacy Pump	Set, i.v. fluid transfer	1,263	0	0%
Amia Automated Pd Cycler Set	System, peritoneal, automatic delivery	1,254	0	0%
VersaCare Med Surg Bed	Bed, ac-powered adjustable hospital	1,152	661	0.3%
Flo-Gard 6201 Volumetric Infusion Pump	Pump, infusion	969	0	0.3%
Progressa Bed System	Bed, ac-powered adjustable hospital	894	539	0%
Capd Solution Transfer Set Short For Uv-Flash	Set, administration, for peritoneal dialysis, disposable	852	0	0%
MiniCap	Dialyzer, high permeability with or without sealed dialysate system	835	409	1.1%
Homechoice Automated Pd Set W/Cassette 4 Prong	System, peritoneal, automatic delivery	831	0	0.1%
Clearlink Continu-Flo Solution Set	Set, administration, intravascular	827	6	0.1%
Prismaflex Sets (St)	Dialyzer, high permeability with or without sealed dialysate system	659	466	0.4%
Exactamix Eva Bag	Container, i.v.	653	0	0%
Spectrum With Mdl	Pump, infusion	631	142	0.1%
Clearlink/Continu-Flo/Duo-Vent	Set, administration, intravascular	597	282	0%
Clearlink/Continu-Flo	Set, administration, intravascular	585	331	0.1%
Psn Dialyzer Psn 210	Dialyzer, high permeability with or without sealed dialysate system	579	0	0.8%

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
FRN	Pump, infusion	147,536	52.9%
KDJ	Set, administration, for peritoneal dialysis, disposable	47,763	17.1%
FKX	System, peritoneal, automatic delivery	28,270	10.1%
FPA	Set, administration, intravascular	14,487	5.2%
MEB	Pump, infusion, elastomeric	10,017	3.6%
LHI	Set, i.v. fluid transfer	6,596	2.4%
KDI	Dialyzer, high permeability with or without sealed dialysate system	6,566	2.4%
FNL	Bed, ac-powered adjustable hospital	4,138	1.5%
KPE	Container, i.v.	1,162	0.4%
FJI	Dialyzer, capillary, hollow fiber	943	0.3%

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

Death1.1%3,038

Injury15.5%43,290

Malfunction83%231,593

Other0.3%784

Not given0.2%436

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 reports

How many FDA device reports name Baxter Healthcare as manufacturer?

279,141 reports through August 2026, 11,947 of them in the latest 12 months.

Which of its brands appear most often?

Spectrum Infusion Pump (127,007), Ni (22,648), Spectrum Iq Infusion Pump (5,908), Infusor (4,854) and FOLFusor (4,222).

Which device types does it report on?

pump, infusion (52.9%), set, administration, for peritoneal dialysis, disposable (17.1%), system, peritoneal, automatic delivery (10.1%) and set, administration, intravascular (5.2%).

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.