Devices › Set, administration, intravascular
Device brand name · Intravascular administration set
BD Alaris Pump Module SmartSite Infusion Set: medical device reports filed with FDA
1,854 reports name it, 2020–2026. Manufacturer given most often on reports: Sistemas Medicos Alaris De C V. Product code FPA.
- 1,854
- device reports naming the brand
- 0% of all MAUDE reports · about 323 a year
- 346
- reports, 12 months to August 2026
- 433 in the 12 months before
- 99.3%
- classified as malfunction
- 79.3% across the product code
- 0.3%
- classified as death, as reported
- 5 reports · not verified by FDA
1,854 medical device reports received by FDA name the brand "BD Alaris Pump Module SmartSite Infusion Set" (intravascular administration set); the manufacturer given most often on reports is Sistemas Medicos Alaris De C V; received from October 2020 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
346 reports arrived in the 12 months to August 2026, down 20% from 433 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 (99.3%), injury (0.4%) and death (0.3%); across all set, administration, intravascular reports (product code FPA) death is recorded in 0.2% and malfunction in 79.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are leak/splash (35.5%), material separation (13.6%) and air/gas in device (7.8%). The patient problems coded most often are chemical exposure, awareness during anesthesia and hemorrhage/blood loss/bleeding. 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."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 349,387 reports carrying product code FPA. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Leak/splashthe device leaked | 659 | 35.5% | 11.2% |
| Material separation | 253 | 13.6% | 1.8% |
| Air/gas in device | 144 | 7.8% | 0.9% |
| Defective component | 136 | 7.3% | 0.5% |
| Breakthe device broke | 116 | 6.3% | 2.1% |
| Backflow | 101 | 5.4% | 0.5% |
| Complete blockage | 81 | 4.4% | 4.2% |
| Infusion or flow problema problem with flow or infusion | 57 | 3.1% | 3% |
| Free or unrestricted flow | 46 | 2.5% | 0.3% |
| Material puncture/hole | 44 | 2.4% | 0.3% |
| Crackthe device cracked | 41 | 2.2% | 1.5% |
| Fluid/blood leak | 39 | 2.1% | 13.5% |
| Separation problem | 38 | 2% | 0.2% |
| Disconnection | 27 | 1.5% | 1.8% |
| Excess flow or over-infusion | 27 | 1.5% | 0.4% |
| Deformation due to compressive stress | 26 | 1.4% | 0.2% |
| Detachment of device or device componentpart of the device came off | 24 | 1.3% | 3.9% |
| Improper flow or infusion | 24 | 1.3% | 0.4% |
| Material deformation | 23 | 1.2% | 0.8% |
| Component missing | 22 | 1.2% | 0.2% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Chemical exposure | 9 | 0.5% |
| Awareness during anesthesia | 3 | 0.2% |
| Hemorrhage/blood loss/bleeding | 3 | 0.2% |
| Abdominal painstomach or belly pain | 2 | 0.1% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 2 | 0.1% |
| High blood pressure/ hypertension | 2 | 0.1% |
| Hyperglycemiahigh blood sugar | 2 | 0.1% |
| Hypertrophy | 2 | 0.1% |
| Hypoglycemialow blood sugar | 2 | 0.1% |
| Low blood pressure/ hypotension | 2 | 0.1% |
| Altered state of consciousness | 1 | 0.1% |
| Anaphylactic shocka severe allergic reaction with collapse | 1 | 0.1% |
| Brain injury | 1 | 0.1% |
| Burning sensationa burning feeling | 1 | 0.1% |
| Cardiac arrestthe heart stopped | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | BD Alaris Pump Module SmartSite Infusion Set | Product code FPA | All MAUDE reports |
|---|---|---|---|
| Reports | 1,854 | 349,387 | 26,136,888 |
| Share of that pool | — | 0.5% | 0% |
| Classified as death, per 1,000 reports | 3 | 2 | 9 |
| Classified as injury | 0.4% | 20% | 36.2% |
| Classified as malfunction | 99.3% | 79.3% | 62.3% |
| Filed by the manufacturer | 100% | 96.3% | 94.9% |
Shares are of reports, not 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."
Other brands with product code FPA
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Inset Guard | 47,276 | 47,222 | 0.1% |
| Inset | 26,405 | 25,656 | 0% |
| Quick Set | 23,351 | 23,028 | 0.4% |
| Autosoft Xc | 20,328 | 49 | 0% |
| Autosoft 90 | 12,143 | 15 | 0% |
| Access | 14,160 | 0 | 0% |
| Other Accessories | 10,429 | 10,425 | 1.7% |
| Alaris Pump Module Administration Set | 8,492 | 0 | 0.2% |
| Contact Detach | 6,473 | 6,157 | 0.1% |
| Inset 30 | 3,528 | 3,461 | 0% |
| Cadd | 10,811 | 9 | 0.1% |
| Minimed Quick-Set | 3,101 | 6 | 0% |
| Cleo 90 Infusion Set | 3,006 | 23 | 0% |
| Trusteel | 2,886 | 14 | 0% |
| Autosoft 30 | 2,374 | 1 | 0% |
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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about BD Alaris Pump Module SmartSite Infusion Set reports
How many FDA reports name BD Alaris Pump Module SmartSite Infusion Set?
1,854 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 346 in the latest 12 months.
What kinds of events are reported?
malfunction (99.3%), injury (0.4%) and death (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
leak/splash (35.5%), material separation (13.6%), air/gas in device (7.8%), defective component (7.3%) and break (6.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that BD Alaris Pump Module SmartSite Infusion Set was at fault?
No. 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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.