Device manufacturer, as written on reports

Sistemas Medicos Alaris De C V: medical device reports filed with FDA

15,931 reports name it as the manufacturer of the device involved, 2000–2026.

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.

15,931
reports naming it as manufacturer: 0.1% of all MAUDE reports; 3,792
reports, 12 months to August 2026: 3,396 in the 12 months before; 99.2%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

15,931 medical device reports received by FDA give Sistemas Medicos Alaris De C V as the manufacturer of the device involved, 0.1% of the MAUDE database, from February 2000 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

3,792 reports arrived in the 12 months to August 2026, up 12% from 3,396 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 (99.2%), injury (0.7%) and death (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 Alaris Pump Module SmartSite Infusion Set	Set, administration, intravascular	1,813	346	0.3%
Unspecified BD Infusion Set	Set, administration, intravascular	1,179	484	0.2%
BD Alaris SmartSite Pump Infusion Set	Set, administration, intravascular	1,080	748	0.1%
BD MaxZero Needleless Connector	Set, administration, intravascular	636	241	0%
BD Alaris SmartSite Extension Set	Set, administration, intravascular	554	149	0%
BD Alaris SmartSite Needle-Free Valve	Set, administration, intravascular	522	87	0%
Alaris, SmartSite	Set, administration, intravascular	377	316	0.1%
Bd Alaris Pump Module Smartsite Low Sorbing Infusion Set	Set, administration, intravascular	313	1	0%
BD Alaris SmartSite Gravity Set	Set, administration, intravascular	283	56	0%
BD Alaris Extension Set	Set, administration, intravascular	226	34	0.4%
Maxzero	Set, administration, intravascular	217	231	0.3%
Bd Maxzero Multi-Fuse Extension Set With Needleless Connector	Set, administration, intravascular	207	3	0%
BD Alaris Secondary Set	Set, administration, intravascular	204	13	0%
BD Alaris Pump Module Infusion Set	Set, administration, intravascular	187	10	0%
BD Maxzero extension set	Set, administration, intravascular	174	102	0%
BD MaxPlus Pressure Rated Extension Set with Removable Needleless Connector	Set, administration, intravascular	155	13	0%
BD MaxGuard Extension Set	Set, administration, intravascular	150	50	0%
As Lvp 20d 2ss Cv	Set, administration, intravascular	149	20	0%
Smallbore 6 Inch Ext Vlv	Set, administration, intravascular	137	0	0%
Ll Vlv Adpt Stand Alone	Set, administration, intravascular	132	6	0%
Maxzero Needleless Connector	Set, administration, intravascular	109	13	0%
As Lvp 20d Dehp 2ss Cv	Set, administration, intravascular	104	0	0%
As Lvp 20d Dehp 3ss Cv	Set, administration, intravascular	103	0	1.1%
As Lvp 20d 3ss Cv	Set, administration, intravascular	94	8	0%
Alaris	Pump, infusion	80	79	1.1%
Administration Set	Set, administration, intravascular	68	2	1.4%
BD alaris pump infusion set	Set, administration, intravascular	61	55	1.1%
Maxplus Positive Pressure Connector	Set, administration, intravascular	22	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
FPA	Set, administration, intravascular	15,752	98.9%
FMF	Syringe, piston	67	0.4%
LHI	Set, i.v. fluid transfer	49	0.3%
FOZ	Catheter, intravascular, therapeutic, short-term less than 30 days	21	0.1%
ONB	Closed antineoplastic and hazardous drug reconstitution and transfer system	21	0.1%
NGT	Saline, vascular access flush	8	0.1%
FMI	Needle, hypodermic, single lumen	3	0%
BRY	Cabinet, table and tray, anesthesia	1	0%
FMG	Stopcock, i.v. set	1	0%
FRN	Pump, infusion	1	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

Death0.1%18

Injury0.7%111

Malfunction99.2%15,802

Other0%0

Not given0%0

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

Questions about Sistemas Medicos Alaris De C V reports

How many FDA device reports name Sistemas Medicos Alaris De C V as manufacturer?

15,931 reports through August 2026, 3,792 of them in the latest 12 months.

Which of its brands appear most often?

BD Alaris Pump Module SmartSite Infusion Set (1,813), Unspecified BD Infusion Set (1,179), BD Alaris SmartSite Pump Infusion Set (1,080), BD MaxZero Needleless Connector (636) and BD Alaris SmartSite Extension Set (554).

Which device types does it report on?

set, administration, intravascular (98.9%), syringe, piston (0.4%), set, i.v. fluid transfer (0.3%) and catheter, intravascular, therapeutic, short-term less than 30 days (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.