Reported Reactions

Devices › Pump, infusion

Device brand name · Pump infusion

CADD Legacy Plus Pump: medical device reports filed with FDA

2,530 reports name it, 2018–2026. Manufacturer given most often on reports: St Paul. Product code FRN.

2,530
device reports naming the brand
0% of all MAUDE reports · about 334 a year
617
reports, 12 months to August 2026
406 in the 12 months before
99.8%
classified as malfunction
98.5% across the product code
0%
classified as death, as reported
1 reports · not verified by FDA

FDA's MAUDE database holds 2,530 reports that name the brand "CADD Legacy Plus Pump" (pump infusion), received between December 2018 and August 2026; the manufacturer given most often on reports is St Paul. Spellings of one product vary from report to report.

617 reports arrived in the 12 months to August 2026, up 52% from 406 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 (99.8%) and injury (0.2%); across all pump, infusion reports (product code FRN) death is recorded in 0.1% and malfunction in 98.5%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are device alarm system (39.7%), failure to infuse (22.7%) and device sensing problem (8.8%). The patient problems coded most often are no patient involvement, nausea and pain. 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

078156Sep 2021: 40Oct 2021: 15Nov 2021: 25Dec 2021: 152022Jan 2022: 2Feb 2022: 3Mar 2022: 27Apr 2022: 24May 2022: 139Jun 2022: 156Jul 2022: 103Aug 2022: 22Sep 2022: 33Oct 2022: 35Nov 2022: 31Dec 2022: 292023Jan 2023: 20Feb 2023: 0Mar 2023: 3Apr 2023: 0May 2023: 1Jun 2023: 1Jul 2023: 0Aug 2023: 0Sep 2023: 1Oct 2023: 0Nov 2023: 1Dec 2023: 32024Jan 2024: 18Feb 2024: 27Mar 2024: 30Apr 2024: 27May 2024: 21Jun 2024: 14Jul 2024: 24Aug 2024: 9Sep 2024: 21Oct 2024: 18Nov 2024: 27Dec 2024: 162025Jan 2025: 13Feb 2025: 12Mar 2025: 11Apr 2025: 64May 2025: 48Jun 2025: 70Jul 2025: 74Aug 2025: 32Sep 2025: 55Oct 2025: 45Nov 2025: 66Dec 2025: 592026Jan 2026: 39Feb 2026: 49Mar 2026: 72Apr 2026: 42May 2026: 41Jun 2026: 48Jul 2026: 50Aug 2026: 51

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

03026042018: 820182019: 18820192020: 10820202021: 39920212022: 60420222023: 3020232024: 25220242025: 54920252026: 3922026

Event type and report source

Event type, as classified on the report

Death0%1
Injury0.2%4
Malfunction99.8%2,525
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%2,529
Voluntary report0%1
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 1,831,109 reports carrying product code FRN. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Device alarm system1,00439.7%2.8%
Failure to infuse57522.7%0.4%
Device sensing problem2238.8%3.8%
Insufficient flow or under infusion2078.2%0.8%
Output problem2058.1%0.3%
Failure to sense1234.9%0.9%
Air/gas in device1084.3%0.1%
Connection problema connection problem1074.2%0.1%
Infusion or flow problema problem with flow or infusion732.9%0.3%
Excess flow or over-infusion592.3%1.2%
Improper flow or infusion471.9%0.5%
Volume accuracy problem451.8%0.1%
Inaccurate delivery371.5%0.4%
Mechanical problema mechanical problem281.1%0.3%
Pumping stopped261%0.2%
Battery problema problem with the battery251%1.2%
Fluid/blood leak251%0.6%
Pressure problem251%0.1%
Increase in pressure220.9%0%
Obstruction of flow220.9%0.3%

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)ReportsShare
No patient involvement1485.8%
Nauseafeeling sick40.2%
Painpain, site not specified40.2%
Diarrhea20.1%
Air embolism10%
Arrhythmia10%
Burn(s)a burn10%
Cancer10%
Chemical exposure10%
Dyspneashortness of breath10%
Fatiguetiredness10%
Skin discoloration10%
Tachycardiafast heart rate10%
Urethral stenosis/stricture10%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureCADD Legacy Plus PumpProduct code FRNAll MAUDE reports
Reports2,5301,831,10926,136,888
Share of that pool—0.1%0%
Classified as death, per 1,000 reports019
Classified as injury0.2%1.3%36.2%
Classified as malfunction99.8%98.5%62.3%
Filed by the manufacturer100%99.1%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 FRN

BrandReportsLatest 12 monthsClassified as death
Alaris Pump Module684,52200%
Alaris System422,50133,6920%
8100 Alaris Pump Module163,62000%
Spectrum Infusion Pump147,363150%
8015 Alaris System Pc Unit54,16200%
Alaris System Pc Unit24,06600%
8110 Alaris Syringe Pump22,43400%
Colleague21,76300%
Reservoir 3ML MMT-332A19,9142,0080.4%
Reservoir 3ml16,40700.8%
Flogard15,66800%
Colleague Volumetric Infusion Pump13,67800.1%
Colleague Pre P1 713,10300%
CADD-Solis VIP Ambulatory Infusion Pump11,7213,4710.1%
Intermate8,261470%

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 CADD Legacy Plus Pump reports

How many FDA reports name CADD Legacy Plus Pump?

2,530 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 617 in the latest 12 months.

What kinds of events are reported?

malfunction (99.8%) and injury (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

device alarm system (39.7%), failure to infuse (22.7%), device sensing problem (8.8%), insufficient flow or under infusion (8.2%) and output problem (8.1%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%) and voluntary reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that CADD Legacy Plus Pump 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.