What are FDA adverse event reports for Apparatus, Autotransfusion?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Apparatus, Autotransfusion, there are 3,115 total reports including 82 death reports and 438 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 Apparatus, Autotransfusion?

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

Apparatus, Autotransfusion

Name: Apparatus, Autotransfusion - 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 Apparatus, Autotransfusion LIGHT-BOOK · MAUDE

#381 of 1000 · 3,115 reports · 1992–2026

BOOK 3,115 reports
RANK #381 of 1000
DEATH 82 death-typed
INJ 438 injury-typed
MALF 2,492 malfunction
SPAN 1992–2026
PEAK 2011: 939
PHOTO Unit

Nearest event-volume peer: Unit, Cryosurgical, Accessories (8 report gap)

Apparatus, Autotransfusion sits #381 of 1000 among tracked device types with 3,115 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 2.6% corpus 1.5% · above corpus mean (+1.1 pp)
INJ 14.1% corpus 30.4% · below corpus mean (-16.4 pp)
MALF 80.0% corpus 64.5% · above corpus mean (+15.5 pp)

Lead product-problem code Fluid/Blood Leak is 27% of coded problems · Lead manufacturer ATRIUM MEDICAL CORPORATION accounts for 33% of manufacturer-tagged reports · Top event location is 69% of location-tagged rows .

Scaler

3,134
System

3,131
Apparatus (this)

3,115
Unit

3,107
Monitor

3,091
Collector

3,090

What this shows Apparatus, Autotransfusion carries 3,115 MAUDE reports, ranked #381 of 1000.

Event Types

Malfunction 2,492 (80.0%)

Injury 438 (14.1%)

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.

2,457 (77.8%)

Required Intervention 342 (10.8%)

Other 177 (5.6%)

Death 83 (2.6%)

Hospitalization 34 (1.1%)

R 26 (0.8%)

Life Threatening 17 (0.5%)

O 8 (0.3%)

L 7 (0.2%)

S 3 (0.1%)

Disability 3 (0.1%)

D 1 (0.0%)

Yearly Trend

1992: 1

1993: 3

1994: 17

1995: 22

1996: 49

1997: 51

1998: 48

1999: 51

2000: 56

2001: 39

2002: 26

2003: 35

2004: 32

2005: 15

2006: 50

2007: 34

2008: 12

2009: 68

2010: 115

2011: 939

2012: 249

2013: 153

2014: 90

2015: 87

2016: 73

2017: 88

2018: 87

2019: 64

2020: 108

2021: 73

2022: 65

2023: 39

2024: 129

2025: 128

2026: 19

Top Manufacturers

ATRIUM MEDICAL CORPORATION 187

PERFUSION SYSTEMS 143

MEDTRONIC MEXICO 108

STRYKER INSTRUMENTS-KALAMAZOO 65

MEDTRONIC MEXICO S. DE R.L. DE CV 61

Event Locations

2,134 (68.5%)

I 492 (15.8%)

HOSPITAL 366 (11.7%)

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 similar MAUDE profiles

Two openFDA-derived peer sets for Apparatus, Autotransfusion, 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 (3,115 here).

Unit, Cryosurgical, Accessories 3,107 System 3,131 Scaler, Ultrasonic 3,134 Monitor, Cardiac 3,091

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 Catheter, Septostomy 83 Instrument, Ultrasonic Surgical 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.

Apparatus, Autotransfusion

Event-type mix vs corpus