What are FDA adverse event reports for Warmer, Thermal, Infusion Fluid?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Warmer, Thermal, Infusion Fluid, there are 6,957 total reports including 47 death reports and 144 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe, widely used devices naturally generate more reports.

How should I interpret MAUDE data for Warmer, Thermal, Infusion Fluid?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance, it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2026 data FDA MAUDE openFDA

Warmer, Thermal, Infusion Fluid

Name: Warmer, Thermal, Infusion Fluid - FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

Compiled by PlainHospital · August 14, 2026

OpenFDA device adverse-event casebook.

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FDA MAUDE casebook

openFDA event book Warmer, Thermal, Infusion Fluid LIGHT-BOOK · MAUDE

#259 of 1000 · 6,957 reports · 1992–2026

BOOK 6,957 reports
RANK #259 of 1000
DEATH 47 death-typed
INJ 144 injury-typed
MALF 6,716 malfunction
SPAN 1992–2026
PEAK 2022: 1,548
PHOTO Hearing Aid

Nearest event-volume peer: Hearing Aid, Bone Conduction (16 report gap)

Warmer, Thermal, Infusion Fluid sits #259 of 1000 among tracked device types with 6,957 MAUDE reports spanning 1992–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

DEATH 0.7% corpus 1.5% · below corpus mean (-0.8 pp)
INJ 2.1% corpus 30.4% · below corpus mean (-28.4 pp)
MALF 96.5% corpus 64.5% · above corpus mean (+32.0 pp)

Lead product-problem code Fluid/Blood Leak is 25% of coded problems · Lead manufacturer SMITHS MEDICAL ASD, INC. accounts for 57% of manufacturer-tagged reports · Top event location is 64% of location-tagged rows .

Stent, Iliac

6,991
Hearing Aid

6,973
Warmer (this)

6,957
Laryngoscope

6,912
Heart-Valve

6,889
Prosthesis

6,864

What this shows Warmer, Thermal, Infusion Fluid carries 6,957 MAUDE reports, ranked #259 of 1000.

Event Types

Malfunction 6,716 (96.5%)

Injury 144 (2.1%)

Death 47 (0.7%)

Other 27 (0.4%)

23 (0.3%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

6,671 (95.6%)

Required Intervention 101 (1.4%)

Other 80 (1.1%)

Hospitalization 38 (0.5%)

Death 37 (0.5%)

Life Threatening 15 (0.2%)

R 13 (0.2%)

L 7 (0.1%)

O 7 (0.1%)

Disability 5 (0.1%)

D 2 (0.0%)

H 1 (0.0%)

S 1 (0.0%)

Yearly Trend

1992: 1

1993: 1

1994: 3

1995: 3

1996: 8

1997: 7

1998: 9

1999: 18

2000: 4

2001: 8

2002: 50

2003: 38

2004: 19

2005: 51

2006: 23

2007: 11

2008: 10

2009: 12

2010: 43

2011: 54

2012: 52

2013: 16

2014: 23

2015: 34

2016: 15

2017: 58

2018: 94

2019: 340

2020: 1,221

2021: 885

2022: 1,548

2023: 1,033

2024: 862

2025: 380

2026: 23

Top Manufacturers

SMITHS MEDICAL ASD, INC. 1,667

ST PAUL 865

SMITHS MEDICAL ASD, INC 199

SMITHS MEDICAL ASD; INC. 125

ICU MEDICAL, INC. 90

Event Locations

4,473 (64.3%)

I 2,259 (32.5%)

HOSPITAL 183 (2.6%)

NO INFORMATION 20 (0.3%)

NOT APPLICABLE 9 (0.1%)

INVALID DATA 5 (0.1%)

UNKNOWN 5 (0.1%)

OTHER 2 (0.0%)

AMBULATORY SURGICAL FACILITY 1 (0.0%)

Compare SMITHS MEDICAL ASD, INC. vs ST PAUL →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Warmer, Thermal, Infusion Fluid, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (6,957 here).

Hearing Aid, Bone Conduction 6,973 Stent, Iliac 6,991 Laryngoscope, Rigid 6,912 Heart-Valve, Mechanical 6,889

Similar death-typed counts

Nearest other device types by death-typed report count (47 here), distinct from the volume row.

Bone Cement, Antibiotic 47 Control, Pump Speed, Cardiopulmonary Bypass 47 Prosthesis 47 Pulmonic Valved Conduit 48

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Warmer, Thermal, Infusion Fluid are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Warmer, Thermal, Infusion Fluid; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.

Warmer, Thermal, Infusion Fluid

Event-type mix vs corpus