What are FDA adverse event reports for Set, Blood Transfusion?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Set, Blood Transfusion, there are 1,807 total reports including 9 death reports and 40 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 Set, Blood Transfusion?

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

Set, Blood Transfusion

Name: Set, Blood Transfusion - 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.

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Set, Blood Transfusion LIGHT-BOOK · MAUDE

#507 of 1000 · 1,807 reports · 1994–2026

BOOK 1,807 reports
RANK #507 of 1000
DEATH 9 death-typed
INJ 40 injury-typed
MALF 1,718 malfunction
SPAN 1994–2026
PEAK 2013: 175
PHOTO Catheter, Septostomy

Nearest event-volume peer: Catheter, Septostomy (10 report gap)

Set, Blood Transfusion sits #507 of 1000 among tracked device types with 1,807 MAUDE reports spanning 1994–2026. 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 0.5% corpus 1.5% · below corpus mean (-1.0 pp)
INJ 2.2% corpus 30.4% · below corpus mean (-28.2 pp)
MALF 95.1% corpus 64.5% · above corpus mean (+30.6 pp)

Lead product-problem code Fluid/Blood Leak is 43% of coded problems · Lead manufacturer BAXTER HEALTHCARE CORPORATION accounts for 39% of manufacturer-tagged reports · Top event location is 60% of location-tagged rows .

Pump

1,832
Catheter

1,827
Set (this)

1,807
Catheter

1,797
Generator

1,784
Operating Roo…

1,781

What this shows Set, Blood Transfusion carries 1,807 MAUDE reports, ranked #507 of 1000.

Event Types

Malfunction 1,718 (95.1%)

Injury 40 (2.2%)

Other 27 (1.5%)

13 (0.7%)

Death 9 (0.5%)

Patient Outcomes

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

1,662 (91.7%)

Other 101 (5.6%)

Required Intervention 23 (1.3%)

Death 9 (0.5%)

R 4 (0.2%)

Disability 4 (0.2%)

Life Threatening 4 (0.2%)

Hospitalization 3 (0.2%)

H 1 (0.1%)

L 1 (0.1%)

Yearly Trend

1994: 8

1995: 7

1996: 11

1997: 22

1998: 19

1999: 22

2000: 5

2001: 10

2002: 10

2003: 25

2004: 18

2005: 31

2006: 25

2007: 12

2008: 12

2009: 17

2010: 71

2011: 123

2012: 141

2013: 175

2014: 108

2015: 171

2016: 78

2017: 82

2018: 66

2019: 85

2020: 90

2021: 60

2022: 55

2023: 67

2024: 89

2025: 70

2026: 22

Top Manufacturers

BAXTER HEALTHCARE CORPORATION 458

BAXTER HEALTHCARE - MALTA 322

BAXTER HEALTHCARE 121

BAXTER HEALTHCARE - AIBONITO 118

BAXTER HEALTHCARE - SINGAPORE 111

BAXTER HEALTHCARE CORP. 55

Event Locations

1,084 (60.0%)

I 482 (26.7%)

HOSPITAL 204 (11.3%)

OUTPATIENT TREATMENT FACILITY 11 (0.6%)

NO INFORMATION 7 (0.4%)

INVALID DATA 5 (0.3%)

NOT APPLICABLE 4 (0.2%)

UNKNOWN 4 (0.2%)

AMBULATORY SURGICAL FACILITY 3 (0.2%)

CRITICAL CARE UNIT 1 (0.1%)

HOME 1 (0.1%)

OTHER 1 (0.1%)

Compare BAXTER HEALTHCARE CORPORATION vs BAXTER HEALTHCARE - MALTA →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Set, Blood Transfusion, 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 (1,807 here).

Catheter, Septostomy 1,797 Catheter 1,827 Generator, Lesion, Radiofrequency 1,784 Pump 1,832

Similar death-typed counts

Nearest other device types by death-typed report count (9 here), distinct from the volume row.

Blood Establishment Computer Software And A… 9 Catheter, Conduction, Anesthetic 9 Choledochoscope And Accessories 9 Connector, Airway 9

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

Disclaimer: MAUDE figures for Set, Blood Transfusion 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 Set, Blood Transfusion; 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.

Set, Blood Transfusion

Event-type mix vs corpus