Reported Reactions

Devices › Pump, infusion, enteral

Device brand name · Enteral infusion pump

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

2,930 reports name it, 2008–2026. Manufacturer given most often on reports: Moog Medical Devices Group. Product code LZH.

2,930
device reports naming the brand
0% of all MAUDE reports · about 167 a year
233
reports, 12 months to August 2026
277 in the 12 months before
96.9%
classified as malfunction
95.5% across the product code
0.2%
classified as death, as reported
7 reports · not verified by FDA

FDA's MAUDE database holds 2,930 reports that name the brand "Enteralite Infinity Enteral Feeding Pump" (enteral infusion pump), received between December 2008 and August 2026; the manufacturer given most often on reports is Moog Medical Devices Group. Spellings of one product vary from report to report.

233 reports arrived in the 12 months to August 2026, down 16% from 277 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 (96.9%), other (2.1%) and injury (0.7%); 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 protective measures problem (55%), failure to deliver (14.6%) and device displays incorrect message (8.6%). The patient problems coded most often are no patient involvement, overdose and air embolism. 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

03060Sep 2021: 33Oct 2021: 28Nov 2021: 19Dec 2021: 522022Jan 2022: 51Feb 2022: 54Mar 2022: 59Apr 2022: 33May 2022: 26Jun 2022: 29Jul 2022: 51Aug 2022: 60Sep 2022: 28Oct 2022: 29Nov 2022: 27Dec 2022: 192023Jan 2023: 14Feb 2023: 22Mar 2023: 15Apr 2023: 13May 2023: 13Jun 2023: 17Jul 2023: 13Aug 2023: 7Sep 2023: 13Oct 2023: 19Nov 2023: 13Dec 2023: 112024Jan 2024: 34Feb 2024: 13Mar 2024: 14Apr 2024: 9May 2024: 11Jun 2024: 17Jul 2024: 14Aug 2024: 31Sep 2024: 17Oct 2024: 25Nov 2024: 20Dec 2024: 232025Jan 2025: 13Feb 2025: 22Mar 2025: 60Apr 2025: 25May 2025: 15Jun 2025: 35Jul 2025: 15Aug 2025: 7Sep 2025: 35Oct 2025: 18Nov 2025: 19Dec 2025: 222026Jan 2026: 29Feb 2026: 14Mar 2026: 13Apr 2026: 21May 2026: 9Jun 2026: 14Jul 2026: 30Aug 2026: 9

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

02334662008: 420082009: 122010: 3420102011: 1132012: 27820122013: 2382014: 4420142015: 92016: 6620162017: 482018: 5920182019: 1332020: 23720202021: 3662022: 46620222023: 1702024: 22820242025: 2862026: 1392026

Event type and report source

Event type, as classified on the report

Death0.2%7
Injury0.7%20
Malfunction96.9%2,840
Other2.1%62
Not given0%1

Who filed the report

Manufacturer report99.5%2,916
Voluntary report0.5%14
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
Protective measures problem1,61255%11.6%
Failure to deliverthe device did not deliver the dose or item42814.6%3.4%
Device displays incorrect message2518.6%2.7%
Insufficient flow or under infusion1003.4%3.6%
Device operates differently than expectedthe device behaved unexpectedly903.1%2.1%
Failure to shut off732.5%0.6%
Excess flow or over-infusion662.3%6.3%
Device alarm system652.2%3.6%
Infusion or flow problema problem with flow or infusion612.1%1.8%
Nonstandard device571.9%0.4%
Failure to auto stop461.6%1.3%
Device remains activated331.1%0.3%
Loss of powerthe device lost power331.1%4.6%
Defective alarm210.7%0.4%
Failure to power up190.6%0.5%
Pumping problem180.6%0.3%
Air leak160.5%0.2%
Mechanical problema mechanical problem130.4%0.6%
Inaccurate delivery100.3%2.6%
No flow90.3%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)ReportsShare
No patient involvement381.3%
Overdosea dose above the recommended amount240.8%
Air embolism90.3%
Vomitingbeing sick70.2%
Underdoseless than the intended dose60.2%
Discomfortdiscomfort50.2%
Missed dose50.2%
Deaththe patient died; cause not stated by this term30.1%
Dehydrationdehydration30.1%
Feeding problem30.1%
Hypoglycemialow blood sugar30.1%
Seizures30.1%
Aspiration/inhalation20.1%
Chokingchoking20.1%
Irritabilityirritability20.1%

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

In context

MeasureEnteralite Infinity Enteral Feeding PumpProduct code LZHAll MAUDE reports
Reports2,93014,92426,136,888
Share of that pool—19.6%0%
Classified as death, per 1,000 reports269
Classified as injury0.7%2.6%36.2%
Classified as malfunction96.9%95.5%62.3%
Filed by the manufacturer99.5%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%
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%
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 Feeding Pump reports

How many FDA reports name Enteralite Infinity Enteral Feeding Pump?

2,930 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 233 in the latest 12 months.

What kinds of events are reported?

malfunction (96.9%), other (2.1%) and injury (0.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

protective measures problem (55%), failure to deliver (14.6%), device displays incorrect message (8.6%), insufficient flow or under infusion (3.4%) and device operates differently than expected (3.1%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (99.5%) and voluntary reports (0.5%). 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 Feeding 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.