Reported Reactions

Devices › Pump, infusion, enteral

Device brand name · Enteral infusion pump

Enteralite Infinity Enteral Infusion Pump: medical device reports filed with FDA

202 reports name it, 2015–2025. Manufacturer given most often on reports: Moog Medical Devices Group. Product code LZH.

202
device reports naming the brand
0% of all MAUDE reports · about 19 a year
3
reports, 12 months to August 2026
2 in the 12 months before
100%
classified as malfunction
95.5% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

202 medical device reports received by FDA name the brand "Enteralite Infinity Enteral Infusion Pump" (enteral infusion pump); the manufacturer given most often on reports is Moog Medical Devices Group; received from October 2015 to December 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

3 reports arrived in the 12 months to August 2026, up 50% from 2 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 (100%); 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 failure to auto stop (38.1%), insufficient flow or under infusion (18.8%) and protective measures problem (9.9%). 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

036Sep 2021: 1Oct 2021: 1Nov 2021: 1Dec 2021: 02022Jan 2022: 0Feb 2022: 1Mar 2022: 1Apr 2022: 0May 2022: 2Jun 2022: 1Jul 2022: 0Aug 2022: 2Sep 2022: 0Oct 2022: 1Nov 2022: 2Dec 2022: 02023Jan 2023: 0Feb 2023: 4Mar 2023: 3Apr 2023: 0May 2023: 2Jun 2023: 0Jul 2023: 0Aug 2023: 1Sep 2023: 0Oct 2023: 0Nov 2023: 0Dec 2023: 02024Jan 2024: 1Feb 2024: 1Mar 2024: 4Apr 2024: 1May 2024: 1Jun 2024: 1Jul 2024: 6Aug 2024: 5Sep 2024: 0Oct 2024: 0Nov 2024: 1Dec 2024: 02025Jan 2025: 0Feb 2025: 0Mar 2025: 1Apr 2025: 0May 2025: 0Jun 2025: 0Jul 2025: 0Aug 2025: 0Sep 2025: 0Oct 2025: 1Nov 2025: 0Dec 2025: 22026Jan 2026: 0Feb 2026: 0Mar 2026: 0Apr 2026: 0May 2026: 0Jun 2026: 0Jul 2026: 0Aug 2026: 0

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

021422015: 920152016: 112017: 2620172018: 282019: 2620192020: 422021: 1520212022: 102023: 1020232024: 212025: 42025

Event type and report source

Event type, as classified on the report

Death0%0
Injury0%0
Malfunction100%202
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%202
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
Failure to auto stop7738.1%1.3%
Insufficient flow or under infusion3818.8%3.6%
Protective measures problem209.9%11.6%
Excess flow or over-infusion157.4%6.3%
Improper flow or infusion52.5%0.5%
Failure to deliverthe device did not deliver the dose or item21%3.4%
Electrical power problem10.5%0.1%
Fire10.5%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.

In context

MeasureEnteralite Infinity Enteral Infusion PumpProduct code LZHAll MAUDE reports
Reports20214,92426,136,888
Share of that pool—1.4%0%
Classified as death, per 1,000 reports069
Classified as injury0%2.6%36.2%
Classified as malfunction100%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%
Cadd-Legacy Duodopa Ambulatory Infusion Pump20300.5%
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 Enteralite Infinity Enteral Infusion Pump reports

How many FDA reports name Enteralite Infinity Enteral Infusion Pump?

202 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 3 in the latest 12 months.

What kinds of events are reported?

malfunction (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

failure to auto stop (38.1%), insufficient flow or under infusion (18.8%), protective measures problem (9.9%), excess flow or over-infusion (7.4%) 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 Enteralite Infinity Enteral 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.