2026 data FDA MAUDE openFDA

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 MAUDE casebook

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

#714 of 1000 · 802 reports · 1999–2026

  • BOOK 802 reports
  • RANK #714 of 1000
  • DEATH 7 death-typed
  • INJ 14 injury-typed
  • MALF 780 malfunction
  • SPAN 1999–2026
  • PEAK 2011: 197
  • PHOTO Lithotriptor

Nearest event-volume peer: Lithotriptor, Extracorporeal Shock-Wave, Urological (1 report gap)

Device, Warming. Blood And Plasma sits #714 of 1000 among tracked device types with 802 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 →

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 0.9% corpus 1.5% · below corpus mean (-0.6 pp)
  • INJ 1.7% corpus 30.4% · below corpus mean (-28.7 pp)
  • MALF 97.3% corpus 64.5% · above corpus mean (+32.8 pp)

Lead product-problem code Fluid/Blood Leak is 44% of coded problems · Lead manufacturer SMITHS MEDICAL ASD, INC. accounts for 42% of manufacturer-tagged reports · Top event location is 55% 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 802 MAUDE reports, ranked #714 of 1000.

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

Event Types

Malfunction 780 (97.3%)
Injury 14 (1.7%)
Death 7 (0.9%)
1 (0.1%)

Patient Outcomes

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

774 (94.9%)
Death 9 (1.1%)
Required Intervention 7 (0.9%)
R 6 (0.7%)
Hospitalization 4 (0.5%)
Other 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 228
Leak/Splash 89
Deformation Due to Compressive Stress 22
Break 19
Scratched Material 18
Connection Problem 15
Infusion or Flow Problem 15
Obstruction of Flow 14
Fitting Problem 13
Insufficient Flow or Under Infusion 10
Component Missing 9
Disconnection 9
Crack 8
Improper Flow or Infusion 8
Device Damaged Prior to Use 7
Material Separation 7
Defective Component 6
Detachment of Device or Device Component 6
Overheating of Device 5
Temperature Problem 5

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: 11

Related Entities for Device, Warming. Blood And Plasma

Event Locations

445 (55.5%)
HOSPITAL 236 (29.4%)
I 118 (14.7%)
NO INFORMATION 3 (0.4%)

Compare SMITHS MEDICAL ASD, INC. vs ST PAUL →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Device, Warming. Blood And Plasma, 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 (802 here).

Similar death-typed counts

Nearest other device types by death-typed report count (7 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.