CAREFUSION 303

FDA MAUDE device safety record · 2010–2025

What the Data Shows About CAREFUSION 303

CAREFUSION 303 is associated with 8,411 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2010 through 2025. Of the total, 2 are coded as death reports and 4 as injury reports, with the remainder classified as malfunctions or other event types. These counts reflect reports submitted to the FDA by manufacturers, healthcare facilities, and patients — they are raw signal, not adjudicated safety findings, and higher-volume manufacturers or older product portfolios naturally generate larger raw counts.

The reports span 4 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for CAREFUSION 303 should be reviewed at the device-family level rather than company-wide. Across those devices, 3 distinct event types appear in the record, led by Malfunction at 8,405 reports (99.9% of total). Patient-outcome categorizations are reported across 10 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 12 years of MAUDE data, with the peak single-year volume reaching 8,303 reports — trend shape can reflect shifts in device sales, FDA reporting requirements, or post-market recall activity as much as intrinsic device performance. The MAUDE system is one input among many in FDA post-market surveillance and does not draw safety conclusions from individual submissions. All figures reflect the openFDA snapshot refreshed on , and nothing on this page is medical or regulatory advice — consult a qualified clinician or the FDA for current safety communications.

8,411
Total Reports
2
Death Reports
4
Injury Reports
4
Device Types

Event Types

Malfunction 8,405 (99.9%)
Injury 4 (0.0%)
Death 2 (0.0%)

Patient Outcomes

8,325 (99.0%)
Other 39 (0.5%)
Hospitalization 20 (0.2%)
Required Intervention 14 (0.2%)
Congenital Anomaly 5 (0.1%)
Life Threatening 5 (0.1%)
Death 2 (0.0%)
H 1 (0.0%)
R 1 (0.0%)
Disability 1 (0.0%)

Yearly Trend

10
2010: 9
13
2013: 1
15
2015: 3
16
2016: 1
18
2018: 2
19
2019: 1
20
2020: 1
21
2021: 44
22
2022: 42
23
2023: 1
24
2024: 3
25
2025: 8,303

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a manufacturer's products are unsafe — higher-volume manufacturers naturally generate more reports.