Device manufacturer, as written on reports

Carefusion: medical device reports filed with FDA

42,247 reports name it as the manufacturer of the device involved, 2009–2026.

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.

42,247
reports naming it as manufacturer: 0.2% of all MAUDE reports; 288
reports, 12 months to August 2026: 221 in the 12 months before; 83.5%
classified as malfunction: 62.3% across all reports; 1.1%
classified as death, as reported: 0.9% across all reports

42,247 medical device reports received by FDA give Carefusion as the manufacturer of the device involved, 0.2% of the MAUDE database, from July 2009 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

288 reports arrived in the 12 months to August 2026, up 30% from 221 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 (83.5%), injury (14.6%) 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
Alaris Pump Module Administration Set	Set, administration, intravascular	8,200	0	0.2%
Alaris Pump Module	Pump, infusion	6,594	0	0%
Vela Ventilator	Ventilator, continuous, facility use	2,588	0	0.3%
Carefusion	Ventilator, continuous, facility use	1,801	0	1.1%
Alaris Pc Unit	Pump, infusion	1,534	0	0.7%
Avea Ventilator	Ventilator, continuous, facility use	1,460	0	0.5%
Alaris Extension Set	Set, administration, intravascular	826	0	0%
Maxzero Needleless Connector	Set, administration, intravascular	776	13	0%
Alaris Pca Module	Pump, infusion	558	0	3.1%
Ltv 1200 Ventilator	Ventilator, continuous, facility use	528	12	7.8%
Palmtop Ventilator Models Ptv-8 Ptv-10	Ventilator, continuous, facility use	464	0	0.7%
Alaris Syringe Pump Module	Pump, infusion	413	0	0.2%
Alaris Syringe Module	Pump, infusion	376	0	0.9%
Maxplus Clear Needleless Connector	Set, administration, intravascular	319	0	0.6%
Smallbore Extension Set	Set, administration, intravascular	303	0	0%
Smartsite Needle-Free Valve	Set, administration, intravascular	296	0	0%
Extension Set	Set, administration, for peritoneal dialysis, disposable	290	66	1.3%
Smartsite Extension Set	Set, administration, intravascular	287	0	0.3%
BD Surgiphor Sterile Wound Irrigation System	Lavage, jet	266	101	0%
Pyxis Anesthesia System Pas	Cabinet, table and tray, anesthesia	252	0	0%
Alaris System Pc Unit	Pump, infusion	237	0	0%
8100 Alaris Pump Module	Pump, infusion	214	0	0%
3100 High Frequency Oscillating Ventilator Hfov	Ventilator, high frequency	199	0	0.6%
Microbore Extension Set	Set, administration, intravascular	193	0	0%
Alaris Primary Administration Set	Set, administration, intravascular	192	0	0%
Pleurx Pleural Catheter Mini Kit	Apparatus, suction, patient care	176	13	0.9%
Maxplus Extension Set	Set, administration, intravascular	166	0	0%
Alaris Secondary Set	Set, administration, intravascular	162	0	0%
Maxguard Extension Set	Set, administration, intravascular	159	0	0%
Ltv 1000 Ventilator	Ventilator, continuous, facility use	152	0	10.3%

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
FPA	Set, administration, intravascular	18,347	43.4%
FRN	Pump, infusion	10,758	25.5%
CBK	Ventilator, continuous, facility use	7,186	17%
LSZ	Ventilator, high frequency	802	1.9%
DWM	Apparatus, suction, patient care	681	1.6%
GCJ	Laparoscope, general & plastic surgery	277	0.7%
FQH	Lavage, jet	271	0.6%
BRY	Cabinet, table and tray, anesthesia	259	0.6%
KXG	Applicator, absorbent tipped, sterile	171	0.4%
FMF	Syringe, piston	149	0.4%

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%465

Injury14.6%6,178

Malfunction83.5%35,285

Other0.2%105

Not given0.5%214

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

Questions about Carefusion reports

How many FDA device reports name Carefusion as manufacturer?

42,247 reports through August 2026, 288 of them in the latest 12 months.

Which of its brands appear most often?

Alaris Pump Module Administration Set (8,200), Alaris Pump Module (6,594), Vela Ventilator (2,588), Carefusion (1,801) and Alaris Pc Unit (1,534).

Which device types does it report on?

set, administration, intravascular (43.4%), pump, infusion (25.5%), ventilator, continuous, facility use (17%) and ventilator, high frequency (1.9%).

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.