Warmer, thermal, infusion fluid: medical device reports filed with FDA

7,003 reports carry this product code, 1992–2026; 20 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.

7,003
reports with this product code: 0% of all MAUDE reports; 107
reports, 12 months to August 2026: 597 in the 12 months before; 96.4%
classified as malfunction: 62.3% across all reports; 0.7%
classified as death, as reported: 0.9% across all reports

Product code LGZ is FDA's classification for "Warmer, thermal, infusion fluid" (general Hospital panel), a class 2 device. 7,003 medical device reports carry this product code, 0% of the MAUDE database, from January 1992 to August 2026.

107 reports arrived in the 12 months to August 2026, down 82% from 597 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 (96.4%), injury (2.1%) and death (0.7%). 20 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
Level 1 Hotline Fluid Warmer	1,123	1	0%	100%
Level 1 Hotline Blood And Fluid Warmer	749	17	0%	99.5%
Level 1 Hotline Fluid Warmer 390	577	11	0%	100%
Level 1	395	0	0.5%	97.8%
The Belmont Rapid Infuser	331	0	0.6%	97.3%
Level 1 Hotline Low Flow System	214	0	0%	100%
Level 1 Hotline Low Flow System Hl-90	168	0	0%	100%
Level 1 Hotline Low Flow Systems - Hl-90	168	0	0%	100%
Level One	103	31	1.7%	45.9%
Animas Insulin Infusion Pump	33	0	0.3%	88.1%
Level 1 Fast Flow Fluid Warmer	20	29	0.8%	98.9%
Pump Mmt-712lnas Prdgm Ins Sk En Us Ln	4	0	3.3%	20.7%
H-Tronplus	3	0	0.9%	42.9%
NxStage System One	3	120	5.7%	21.2%
Bair Hugger	2	1	2.2%	6.4%
Cadd Extension Sets	2	1	0%	93.3%
Ranger	2	151	1.2%	52.7%
CADD legacy 1 pump	1	23	0.2%	99.6%
Eon Mini IPG, 16-Channel Rechargeable	1	111	0.2%	3.5%
Eon Rechargeable IPG, 16-Channel	1	26	0.6%	7.6%

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
Oakdale	2,229	31.8%
Smiths Medical Asd	2,050	29.3%
St Paul	868	12.4%
Smith S Medical Asd	170	2.4%
Smiths Healthcare Manufacturing De C V	110	1.6%
Icu Medical	102	1.5%
Icu Medical Healthcare Manufacturing De C V	34	0.5%
Animas	33	0.5%
Medtronic Minimed	28	0.4%
Vyaire Medical	26	0.4%
Steris - Montgomery	16	0.2%
Nxstage Medical	10	0.1%
Smiths Medical	6	0.1%
Medtronic Puerto Rico Operations	5	0.1%
Steris	5	0.1%

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

Death0.7%48

Injury2.1%148

Malfunction96.4%6,754

Other0.4%30

Not given0.3%23

Who filed

Manufacturer report96.5%6,758

Voluntary report1.3%88

User facility report0%0

Distributor report0.1%9

Not given2.1%148

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

Device problems coded

Device problem (FDA code)	Reports	Share
Fluid/blood leak	1,507	21.5%
Leak/splashthe device leaked	613	8.8%
Device alarm system	593	8.5%
Temperature problem	448	6.4%
Display or visual feedback problem	290	4.1%
Crackthe device cracked	270	3.9%
Breakthe device broke	245	3.5%
Insufficient heating	220	3.1%
Overheating of device	200	2.9%
No audible alarm	195	2.8%
Defective alarm	185	2.6%
Power problem	182	2.6%
Mechanical problema mechanical problem	166	2.4%
Electrical /electronic property probleman electrical or electronic problem	132	1.9%
Excessive heating	121	1.7%
Defective component	119	1.7%
Failure to pump	117	1.7%
False alarm	117	1.7%
Fracturea broken bone	112	1.6%
Failure to power up	111	1.6%

Questions about warmer, thermal, infusion fluid reports

What is product code LGZ?

FDA's classification code for "Warmer, thermal, infusion fluid", 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?

7,003 reports through August 2026, 107 of them in the latest 12 months.

Which brands appear most often?

Level 1 Hotline Fluid Warmer (1,123), Level 1 Hotline Blood And Fluid Warmer (749), Level 1 Hotline Fluid Warmer 390 (577), Level 1 (395) and The Belmont Rapid Infuser (331). 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.