Device manufacturer, as written on reports

Carefusion 303: medical device reports filed with FDA

115,935 reports name it as the manufacturer of the device involved, 2010–2026.

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.

115,935
reports naming it as manufacturer: 0.4% of all MAUDE reports; 75,907
reports, 12 months to August 2026: 36,933 in the 12 months before; 99.7%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

115,935 medical device reports received by FDA give Carefusion 303 as the manufacturer of the device involved, 0.4% of the MAUDE database, from January 2010 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

75,907 reports arrived in the 12 months to August 2026, up 106% from 36,933 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 (99.7%), injury (0.2%) and other (0.1%). 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
BD Pyxis MedStation ES	Cabinet, table and tray, anesthesia	49,093	33,499	0%
BD Pyxis MedStation ES Auxiliary	Cabinet, table and tray, anesthesia	14,382	9,862	0%
Alaris System	Pump, infusion	11,113	33,692	0%
BD Pyxis Anesthesia Station ES	Cabinet, table and tray, anesthesia	6,844	4,515	0%
Pyxis Medstation Es System	Cabinet, table and tray, anesthesia	5,977	0	0%
BD Pyxis MedStation ES Auxiliary Tower	Cabinet, table and tray, anesthesia	5,488	3,659	0%
BD Pyxis ES Server	Cabinet, table and tray, anesthesia	5,484	4,442	0%
BD Pyxis MedBank Tower	Cabinet, table and tray, anesthesia	4,509	3,170	0%
BD Pyxis ES Refrigerator	Cabinet, table and tray, anesthesia	1,258	949	0%
BD Pyxis MedBank Mini	Cabinet, table and tray, anesthesia	1,067	768	0%
Pyxis Medstation System	Cabinet, table and tray, anesthesia	941	0	0%
BD Pyxis MedStation ES Tower	Cabinet, table and tray, anesthesia	905	634	0%
BD Pyxis Medflex 1000	Cabinet, table and tray, anesthesia	887	676	0%
Alaris	Pump, infusion	695	79	1.1%
Pyxis Anesthesia System Pas	Cabinet, table and tray, anesthesia	496	0	0%
BD Pyxis MedStation 4000	Cabinet, table and tray, anesthesia	480	284	0%
BD Pyxis MedBank Tower Aux	Cabinet, table and tray, anesthesia	472	300	0%
Bd Pyxis Medstation Es System	Cabinet, table and tray, anesthesia	391	5	0.2%
Alaris, SmartSite	Set, administration, intravascular	333	316	0.1%
Bd Pyxis Medbank	Cabinet, table and tray, anesthesia	314	150	0%
Pyxis Medbank System	Cabinet, table and tray, anesthesia	270	0	0%
BD Pyxis Medflex 2000	Cabinet, table and tray, anesthesia	174	120	0%
Bd Pyxis Anesthesia System Es	Cabinet, table and tray, anesthesia	165	2	0%
Bd Pyxis Medbank Twr Mn 12hh-1fh	Cabinet, table and tray, anesthesia	151	151	0%
Bd Pyxis Medstation Es Main	Cabinet, table and tray, anesthesia	135	0	0%
Smartsite	Set, administration, intravascular	100	0	0.5%
Smartsite Infusion Set	Set, administration, intravascular	69	0	0.5%
Maxzero	Set, administration, intravascular	45	231	0.3%
Alaris Pc Unit	Pump, infusion	12	0	0.7%
Alaris Pump Module	Pump, infusion	11	0	0%

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
BRY	Cabinet, table and tray, anesthesia	102,655	88.5%
FRN	Pump, infusion	11,414	9.8%
FPA	Set, administration, intravascular	1,224	1.1%
CCK	Analyzer, gas, carbon-dioxide, gaseous-phase	413	0.4%
MEA	Pump, infusion, pca	278	0.2%
FMF	Syringe, piston	7	0%
LHI	Set, i.v. fluid transfer	3	0%
DQA	Oximeter	2	0%
FCG	Biopsy needle	2	0%
FOZ	Catheter, intravascular, therapeutic, short-term less than 30 days	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%46

Injury0.2%188

Malfunction99.7%115,547

Other0.1%111

Not given0%43

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

Questions about Carefusion 303 reports

How many FDA device reports name Carefusion 303 as manufacturer?

115,935 reports through August 2026, 75,907 of them in the latest 12 months.

Which of its brands appear most often?

BD Pyxis MedStation ES (49,093), BD Pyxis MedStation ES Auxiliary (14,382), Alaris System (11,113), BD Pyxis Anesthesia Station ES (6,844) and Pyxis Medstation Es System (5,977).

Which device types does it report on?

cabinet, table and tray, anesthesia (88.5%), pump, infusion (9.8%), set, administration, intravascular (1.1%) and analyzer, gas, carbon-dioxide, gaseous-phase (0.4%).

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.