2026 data FDA MAUDE openFDA FDA Class II

Warmer, Thermal, Infusion Fluid

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

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §880.5725 (General Hospital panel).

FDA MAUDE casebook

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

#265 of 1000 · 6,999 reports · 1992–2026

  • BOOK 6,999 reports
  • RANK #265 of 1000
  • DEATH 48 death-typed
  • INJ 147 injury-typed
  • MALF 6,751 malfunction
  • SPAN 1992–2026
  • PEAK 2022: 1,548
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer (40 report gap)

Warmer, Thermal, Infusion Fluid sits #265 of 1000 among tracked device types with 6,999 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 →

Malfunction reports run above the device-type norm

Warmer, Thermal, Infusion Fluid carries 96.5% MALFUNCTION-coded reports, 31.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.7% corpus 1.5% · below corpus mean (-0.8 pp)
  • INJ 2.1% corpus 30.3% · below corpus mean (-28.2 pp)
  • MALF 96.5% corpus 64.8% · above corpus mean (+31.6 pp)

Lead product-problem code Fluid/Blood Leak is 25% of coded problems · Lead manufacturer SMITHS MEDICAL ASD, INC. accounts for 56% of manufacturer-tagged reports · Top event location is 64% of location-tagged rows .

Warmer, Thermal, Infusion Fluid in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Warmer, Thermal, Infusion Fluid carries 6,999 MAUDE reports, ranked #265 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 6,751 (96.5%)
Injury 147 (2.1%)
Death 48 (0.7%)
Other 30 (0.4%)
23 (0.3%)

Patient Outcomes

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

6,707 (95.5%)
Required Intervention 101 (1.4%)
Other 84 (1.2%)
Death 38 (0.5%)
Hospitalization 38 (0.5%)
Life Threatening 16 (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%)

Top Product Problems

Fluid/Blood Leak 1,506
Leak/Splash 615
Device Alarm System 596
Temperature Problem 449
Display or Visual Feedback Problem 291
Crack 273
Break 246
Insufficient Heating 221
Overheating of Device 204
No Audible Alarm 195
Defective Alarm 186
Power Problem 182
Mechanical Problem 167
Electrical /Electronic Property Problem 133
Excessive Heating 121
Defective Component 119
Failure to Pump 118
False Alarm 118
Failure to Power Up 115
Fracture 115

Yearly Trend

92
1992: 1
93
1993: 1
94
1994: 3
95
1995: 3
96
1996: 8
97
1997: 7
98
1998: 9
99
1999: 18
00
2000: 4
01
2001: 8
02
2002: 50
03
2003: 38
04
2004: 19
05
2005: 51
06
2006: 23
07
2007: 11
08
2008: 10
09
2009: 12
10
2010: 43
11
2011: 54
12
2012: 52
13
2013: 16
14
2014: 23
15
2015: 34
16
2016: 15
17
2017: 58
18
2018: 94
19
2019: 340
20
2020: 1,221
21
2021: 885
22
2022: 1,548
23
2023: 1,033
24
2024: 862
25
2025: 380
26
2026: 65

Reports fell to 380 in 2025, down from an average of 948 in the two years before.

Related Entities for Warmer, Thermal, Infusion Fluid

Event Locations

4,509 (64.4%)
I 2,259 (32.3%)
HOSPITAL 189 (2.7%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Warmer, Thermal, Infusion Fluid: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (6,999 here).

Similar death-typed counts

Nearest other device types by death-typed report count (48 here), distinct from the volume row.

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.