CAREFUSION SD

FDA MAUDE device safety record · 2014–2026

What the Data Shows About CAREFUSION SD

CAREFUSION SD is associated with 1,368,264 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2014 through 2026. Of the total, 183 are coded as death reports and 1,147 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 11 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for CAREFUSION SD 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 1,366,934 reports (99.9% of total). Patient-outcome categorizations are reported across 14 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 13 years of MAUDE data, with the peak single-year volume reaching 871,325 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.

1,368,264
Total Reports
183
Death Reports
1,147
Injury Reports
11
Device Types

Event Types

Malfunction 1,366,934 (99.9%)
Injury 1,147 (0.1%)
Death 183 (0.0%)

Patient Outcomes

1,364,009 (99.8%)
Other 1,343 (0.1%)
Required Intervention 1,038 (0.1%)
Death 196 (0.0%)
R 46 (0.0%)
Life Threatening 25 (0.0%)
Hospitalization 19 (0.0%)
O 13 (0.0%)
Disability 10 (0.0%)
Congenital Anomaly 9 (0.0%)
D 6 (0.0%)
L 3 (0.0%)
H 2 (0.0%)
S 2 (0.0%)

Yearly Trend

14
2014: 3
15
2015: 21
16
2016: 27
17
2017: 22
18
2018: 78
19
2019: 52
20
2020: 78,464
21
2021: 188,239
22
2022: 871,325
23
2023: 154,734
24
2024: 37,088
25
2025: 33,187
26
2026: 5,024

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.