2026 data FDA MAUDE openFDA FDA Class II

Device, Warming. Blood And Plasma

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 §864.9205 (Hematology panel).

FDA MAUDE casebook

openFDA event book Device, Warming. Blood And Plasma LIGHT-BOOK · MAUDE

#716 of 1000 · 828 reports · 1999–2026

  • BOOK 828 reports
  • RANK #716 of 1000
  • DEATH 8 death-typed
  • INJ 14 injury-typed
  • MALF 805 malfunction
  • SPAN 1999–2026
  • PEAK 2011: 197
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Hemodialysis, Triple Lumen, Non-Implanted (3 report gap)

Device, Warming. Blood And Plasma sits #716 of 1000 among tracked device types with 828 MAUDE reports spanning 1999–2026. 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

Device, Warming. Blood And Plasma carries 97.2% MALFUNCTION-coded reports, 32.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.0% corpus 1.5% · below corpus mean (-0.5 pp)
  • INJ 1.7% corpus 30.3% · below corpus mean (-28.6 pp)
  • MALF 97.2% corpus 64.8% · above corpus mean (+32.4 pp)

Lead product-problem code Fluid/Blood Leak is 45% of coded problems · Lead manufacturer SMITHS MEDICAL ASD, INC. accounts for 42% of manufacturer-tagged reports · Top event location is 57% of location-tagged rows .

Device, Warming. Blood And Plasma in the event-volume neighbourhood

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

reports

What this shows Device, Warming. Blood And Plasma carries 828 MAUDE reports, ranked #716 of 1000.

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

Event Types

Malfunction 805 (97.2%)
Injury 14 (1.7%)
Death 8 (1.0%)
1 (0.1%)

Patient Outcomes

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

798 (94.8%)
Death 10 (1.2%)
Required Intervention 7 (0.8%)
R 6 (0.7%)
Other 5 (0.6%)
Hospitalization 4 (0.5%)
H 3 (0.4%)
L 3 (0.4%)
O 3 (0.4%)
S 2 (0.2%)
Life Threatening 1 (0.1%)

Top Product Problems

Fluid/Blood Leak 352
Leak/Splash 98
Fitting Problem 48
Detachment Of Device Component 38
Kinked 35
Break 24
Deformation Due to Compressive Stress 23
Device Operates Differently Than Expected 20
Material Rupture 19
Scratched Material 19
Obstruction of Flow 16
Connection Problem 15
Infusion or Flow Problem 15
Disconnection 11
Crack 10
Insufficient Flow or Under Infusion 10
Component Missing 9
Improper Flow or Infusion 8
Temperature Problem 8
Device Contamination with Body Fluid 7

Yearly Trend

99
1999: 1
04
2004: 1
05
2005: 1
07
2007: 2
09
2009: 1
10
2010: 4
11
2011: 197
12
2012: 14
13
2013: 42
14
2014: 25
15
2015: 16
16
2016: 10
17
2017: 5
18
2018: 3
19
2019: 2
20
2020: 53
21
2021: 71
22
2022: 102
23
2023: 106
24
2024: 57
25
2025: 78
26
2026: 37

Reports in 2025 (78) held close to the prior two-year average of 82.

Related Entities for Device, Warming. Blood And Plasma

Event Locations

470 (56.8%)
HOSPITAL 237 (28.6%)
I 118 (14.3%)
NO INFORMATION 3 (0.4%)

Compare SMITHS MEDICAL ASD, INC. vs ST PAUL →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Device, Warming. Blood And Plasma: 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 (828 here).

Similar death-typed counts

Nearest other device types by death-typed report count (8 here), distinct from the volume row.

Disclaimer: MAUDE figures for Device, Warming. Blood And Plasma 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 Device, Warming. Blood And Plasma; 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.