Reported Reactions

Devices › Pump, infusion, enteral

Device brand name · Pump infusion enteral

Cadd-Legacy Duodopa Ambulatory Infusion Pump: medical device reports filed with FDA

203 reports name it, 2018–2021. Manufacturer given most often on reports: Smiths Medical Asd. Product code LZH.

203
device reports naming the brand
0% of all MAUDE reports · about 25 a year
0
reports, 12 months to August 2026
0 in the 12 months before
97%
classified as malfunction
95.5% across the product code
0.5%
classified as death, as reported
1 reports · not verified by FDA

203 medical device reports received by FDA name the brand "Cadd-Legacy Duodopa Ambulatory Infusion Pump" (pump infusion enteral); the manufacturer given most often on reports is Smiths Medical Asd; received from May 2018 to May 2021. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

0 reports arrived in the 12 months to August 2026, and none 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 (97%), injury (2.5%) and death (0.5%); across all pump, infusion, enteral reports (product code LZH) death is recorded in 0.6% and malfunction in 95.5%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are excess flow or over-infusion (30%), human-device interface problem (16.3%) and infusion or flow problem (15.8%). The patient problems coded most often are ambulation or postural difficulties, dyskinesia and anxiety. 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

No report naming Cadd-Legacy Duodopa Ambulatory Infusion Pump was received in the five years to August 2026; the latest was received in May 2021.

By year received

0781562018: 320182020: 15620202021: 442021

Event type and report source

Event type, as classified on the report

Death0.5%1
Injury2.5%5
Malfunction97%197
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%203
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 14,924 reports carrying product code LZH. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Excess flow or over-infusion6130%6.3%
Human-device interface problem3316.3%0.2%
Infusion or flow problema problem with flow or infusion3215.8%1.8%
Inaccurate delivery178.4%2.6%
Improper flow or infusion52.5%0.5%
Improper or incorrect procedure or method52.5%0.2%
Device alarm system42%3.6%
Increased pump speed42%0.3%
Device difficult to program or calibrate21%0%
Device fell21%0%
Electrical /electronic property probleman electrical or electronic problem21%0.1%
Inaccurate flow rate21%1.3%
Insufficient flow or under infusion21%3.6%
Complete loss of power10.5%0%
Device remains activated10.5%0.3%
Insufficient device problem information10.5%0.2%
No audible alarm10.5%6.5%

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
Ambulation or postural difficulties146.9%
Dyskinesiainvoluntary movements125.9%
Anxietyanxiety52.5%
Cognitive changes52.5%
Muscle spasm(s)52.5%
Shaking/tremors52.5%
Dyspneashortness of breath42%
Nauseafeeling sick42%
Overdosea dose above the recommended amount42%
Distress31.5%
Fatiguetiredness31.5%
Deaththe patient died; cause not stated by this term21%
Tachycardiafast heart rate21%
Visual disturbances21%
Blood loss10.5%

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

In context

MeasureCadd-Legacy Duodopa Ambulatory Infusion PumpProduct code LZHAll MAUDE reports
Reports20314,92426,136,888
Share of that pool—1.4%0%
Classified as death, per 1,000 reports569
Classified as injury2.5%2.6%36.2%
Classified as malfunction97%95.5%62.3%
Filed by the manufacturer100%95%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 LZH

BrandReportsLatest 12 monthsClassified as death
Kangaroo4,3281170.2%
Enteralite Infinity Enteral Feeding Pump2,9302330.2%
Epump 1000ml Safety Screw Spik1,11100%
Clearstar Pump98200%
Embrace Pump95800%
Kangaroo Epump - New65600.2%
Kangaroo Joey Pump W/Pole Clmp57100.4%
Enteralite Infinity Enteral Infusion Pump20230%
Kangaroo Joeypump W/Pole Clmp15000%
Kangaroo Epump - Rfb15100%
Cadd Legacy Pump1,16040.2%
Infinity193242.1%
Cadd Legacy50400%
Quantum183350.5%
Cadd-Legacy Pump38900.3%

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 Duodopa Ambulatory Infusion Pump reports

How many FDA reports name Cadd-Legacy Duodopa Ambulatory Infusion Pump?

203 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

malfunction (97%), injury (2.5%) and death (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

excess flow or over-infusion (30%), human-device interface problem (16.3%), infusion or flow problem (15.8%), inaccurate delivery (8.4%) and improper flow or infusion (2.5%). 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 Cadd-Legacy Duodopa Ambulatory Infusion 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.