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2026 data FDA MAUDE openFDA FDA Class II

Apparatus, Autotransfusion

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 §868.5830 (Anesthesiology panel).

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FDA MAUDE casebook

openFDA event book Apparatus, Autotransfusion LIGHT-BOOK · MAUDE

#392 of 1000 · 3,163 reports · 1992–2026

  • BOOK 3,163 reports
  • RANK #392 of 1000
  • DEATH 82 death-typed
  • INJ 444 injury-typed
  • MALF 2,534 malfunction
  • SPAN 1992–2026
  • PEAK 2011: 939
  • PHOTO System

Nearest event-volume peer: System, Measurement, Blood-Pressure, Non-Invasive (6 report gap)

Apparatus, Autotransfusion sits #392 of 1000 among tracked device types with 3,163 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 →

Injury-coded reports sit below the device-type norm

Apparatus, Autotransfusion carries 14.0% INJURY-coded reports, 16.3pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.6% corpus 1.5% · above corpus mean (+1.1 pp)
  • INJ 14.0% corpus 30.3% · below corpus mean (-16.3 pp)
  • MALF 80.1% corpus 64.8% · above corpus mean (+15.3 pp)

Lead product-problem code Fluid/Blood Leak is 15% of coded problems · Lead manufacturer ATRIUM MEDICAL CORPORATION accounts for 31% of manufacturer-tagged reports · Top event location is 69% of location-tagged rows .

Apparatus, Autotransfusion in the event-volume neighbourhood

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

reports

What this shows Apparatus, Autotransfusion carries 3,163 MAUDE reports, ranked #392 of 1000.

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

Event Types

Malfunction 2,534 (80.1%)
Injury 444 (14.0%)
Death 82 (2.6%)
Other 75 (2.4%)
28 (0.9%)

Patient Outcomes

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

2,496 (77.9%)
Required Intervention 343 (10.7%)
Other 177 (5.5%)
Death 83 (2.6%)
Hospitalization 37 (1.2%)
R 29 (0.9%)
Life Threatening 17 (0.5%)
O 9 (0.3%)
L 7 (0.2%)
S 3 (0.1%)
Disability 3 (0.1%)
D 1 (0.0%)

Top Product Problems

Fluid/Blood Leak 386
Device Contamination with Body Fluid 337
Nonstandard Device 178
Break 175
Leak/Splash 165
Device Operates Differently Than Expected 148
Crack 137
Failure to Power Up 107
Insufficient Device Problem Information 96
Loss of Power 90
Mechanical Problem 89
Device Displays Incorrect Message 85
Detachment Of Device Component 80
Noise, Audible 78
Device Emits Odor 74
Device Inoperable 71
Infusion or Flow Problem 62
Suction Problem 61
Other (for use when an appropriate device code cannot be identified) 60
Disconnection 57

Yearly Trend

92
1992: 1
93
1993: 3
94
1994: 17
95
1995: 22
96
1996: 49
97
1997: 51
98
1998: 48
99
1999: 51
00
2000: 56
01
2001: 39
02
2002: 26
03
2003: 35
04
2004: 32
05
2005: 15
06
2006: 50
07
2007: 34
08
2008: 12
09
2009: 68
10
2010: 115
11
2011: 939
12
2012: 249
13
2013: 153
14
2014: 90
15
2015: 87
16
2016: 73
17
2017: 88
18
2018: 87
19
2019: 64
20
2020: 108
21
2021: 73
22
2022: 65
23
2023: 39
24
2024: 129
25
2025: 128
26
2026: 67

Reports rose to 128 in 2025, up from an average of 84 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Apparatus, Autotransfusion

Top Manufacturers

ATRIUM MEDICAL CORPORATION 187
PERFUSION SYSTEMS 156
MEDTRONIC MEXICO 108
MEDTRONIC MEXICO S. DE R.L. DE CV 92
STRYKER INSTRUMENTS-KALAMAZOO 65

Event Locations

2,182 (69.0%)
I 492 (15.6%)
HOSPITAL 366 (11.6%)
INVALID DATA 65 (2.1%)
OTHER 42 (1.3%)
NO INFORMATION 13 (0.4%)
UNKNOWN 2 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare ATRIUM MEDICAL CORPORATION vs PERFUSION SYSTEMS →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Apparatus, Autotransfusion: 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 (3,163 here).

System 3,169 Dilator 3,156 Endoscopic Tissue Approximation Device 3,154 Saline, Vascular Access Flush 3,148

Similar death-typed counts

Nearest other device types by death-typed report count (82 here), distinct from the volume row.

Device, Monitoring, Intracranial Pressure 82 Monitor, Apnea, Facility Use 82 Instrument, Ultrasonic Surgical 81 Tubing, Pump, Cardiopulmonary Bypass 81

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

Disclaimer: MAUDE figures for Apparatus, Autotransfusion 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 Apparatus, Autotransfusion; 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.