PlainHospital

BAXTER HEALTHCARE - IRVINE

Manufacturer adverse-event records for BAXTER HEALTHCARE - IRVINE come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 2009–2020 · heavy-book · quiet Death-code · injury-light

Injury-mix signature

BAXTER HEALTHCARE - IRVINE is lighter on Injury codes

Injury-coded event_type share is 0.4% (injury-light tercile) beside 0.01% Death-coded (quiet). Volume band: heavy.

What the Injury-mix reading shows for BAXTER HEALTHCARE - IRVINE

The standout signal for BAXTER HEALTHCARE - IRVINE is Injury-mix: 0.4% Injury-coded (injury-light) beside 0.01% Death-coded, on a heavy-book footprint.

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair BAXTER HEALTHCARE - IRVINE with device-family pages before treating company totals as a safety verdict. Event_type Death and Injury are one code per report; Patient Outcomes below use a separate FDA population.

Reports span 7 device types, led in this extract by Malfunction at 23,314 (99.5% of event_type total). Peak single-year volume reaches 5,619 reports across 12 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

23,429
Total Reports
2
Event-type Death
98
Injury Reports
7
Device Types

Event Types

Malfunction 23,314 (99.5%)
Injury 98 (0.4%)
14 (0.1%)
Death 2 (0.0%)
Other 1 (0.0%)

Patient Outcomes

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

23,331 (99.5%)
Other 38 (0.2%)
Hospitalization 32 (0.1%)
Required Intervention 23 (0.1%)
R 20 (0.1%)
Death 2 (0.0%)
H 1 (0.0%)
Congenital Anomaly 1 (0.0%)
Disability 1 (0.0%)
Life Threatening 1 (0.0%)

Devices (7)

Device Reports
Pump, Infusion, Elastomeric 14,691
Pump, Infusion 8,544
Pump, Infusion, Pca 150
Set, Administration, Intravascular 5
Agent, Absorbable Hemostatic, Collagen Based 2
Set, Administration, For Peritoneal Dialysis, Disposable 2
Set, I.V. Fluid Transfer 1

Yearly Trend

09
2009: 13
10
2010: 1,721
11
2011: 2,303
12
2012: 2,561
13
2013: 1,964
14
2014: 4,629
15
2015: 5,619
16
2016: 1,566
17
2017: 1,227
18
2018: 1,232
19
2019: 574
20
2020: 20

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