Pump, infusion, enteral: medical device reports filed with FDA

14,924 reports carry this product code, 1992–2026; 21 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

14,924
reports with this product code: 0.1% of all MAUDE reports; 304
reports, 12 months to August 2026: 372 in the 12 months before; 95.5%
classified as malfunction: 62.3% across all reports; 0.6%
classified as death, as reported: 0.9% across all reports

Product code LZH is FDA's classification for "Pump, infusion, enteral" (general Hospital panel), a class 2 device. 14,924 medical device reports carry this product code, 0.1% of the MAUDE database, from August 1992 to August 2026.

304 reports arrived in the 12 months to August 2026, down 18% from 372 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 (95.5%), injury (2.6%) and other (0.9%). 21 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Kangaroo	3,539	117	0.2%	97%
Enteralite Infinity Enteral Feeding Pump	2,927	233	0.2%	96.9%
Epump 1000ml Safety Screw Spik	1,013	0	0%	100%
Clearstar Pump	978	0	0%	98.9%
Embrace Pump	958	0	0%	99.8%
Kangaroo Epump - New	631	0	0.2%	98.6%
Kangaroo Joey Pump W/Pole Clmp	532	0	0.4%	98.4%
Enteralite Infinity Enteral Infusion Pump	202	3	0%	100%
Cadd-Legacy Duodopa Ambulatory Infusion Pump	195	0	0.5%	97%
Kangaroo Joeypump W/Pole Clmp	149	0	0%	98%
Kangaroo Epump - Rfb	142	0	0%	99.3%
Cadd Legacy Pump	8	4	0.2%	91.6%
Infinity	8	24	2.1%	45.6%
Cadd Legacy	5	0	0%	63.3%
Quantum	5	35	0.5%	66.7%
Cadd-Legacy Pump	4	0	0.3%	97.4%
Cadd	1	9	0.1%	98.9%
CADD Pump	1	27	0.8%	83.9%
Extension Set	1	66	1.3%	56.6%
Kendall	1	23	2.3%	61.5%
Replacement Tube	1	0	0.5%	88.5%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Covidien	6,761	45.3%
Moog Medical Devices Group	3,165	21.2%
Ross Products Division	1,517	10.2%
Smiths Medical Asd	294	2%
Cardinal Health	276	1.8%
Covidien Medical Products	225	1.5%
Cardinal Health 200	120	0.8%
Smiths Medical	23	0.2%
Abbott Laboratories	18	0.1%
St Paul	2	0%
Disetronic Medical Systems	1	0%
Insulet	1	0%
Medela	1	0%
Moog Device Group	1	0%
Smiths Medical International	1	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0.6%85

Injury2.6%394

Malfunction95.5%14,257

Other0.9%140

Not given0.3%48

Who filed

Manufacturer report95%14,178

Voluntary report2.4%362

User facility report0%0

Distributor report0.1%8

Not given2.5%376

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Fluid/blood leak	1,872	12.5%
Protective measures problem	1,725	11.6%
Component(s), broken	1,688	11.3%
No audible alarm	970	6.5%
Excess flow or over-infusion	933	6.3%
No display/image	835	5.6%
Loss of powerthe device lost power	681	4.6%
Device alarm system	541	3.6%
Insufficient flow or under infusion	540	3.6%
Failure to deliverthe device did not deliver the dose or item	508	3.4%
Device displays incorrect message	399	2.7%
Inaccurate delivery	395	2.6%
Overdelivery	329	2.2%
Device operates differently than expectedthe device behaved unexpectedly	313	2.1%
Infusion or flow problema problem with flow or infusion	265	1.8%
Air/gas in device	259	1.7%
Leak/splashthe device leaked	245	1.6%
Underdelivery	213	1.4%
Inaccurate flow rate	200	1.3%
Thermal decomposition of device	199	1.3%

Questions about pump, infusion, enteral reports

What is product code LZH?

FDA's classification code for "Pump, infusion, enteral", class 2, reviewed by the general Hospital panel. Every device report carries the product code of the device involved.

How many reports carry this code?

14,924 reports through August 2026, 304 of them in the latest 12 months.

Which brands appear most often?

Kangaroo (3,539), Enteralite Infinity Enteral Feeding Pump (2,927), Epump 1000ml Safety Screw Spik (1,013), Clearstar Pump (978) and Embrace Pump (958). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.