Pump, Infusion
Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.
OpenFDA device adverse-event casebook.
FDA Class II (moderate risk, special controls required), regulated under 21 CFR §880.5725 (General Hospital panel).
FDA MAUDE casebook
openFDA event book Pump, Infusion HEAVY-BOOK · MAUDE
#3 of 1000 · 1,827,009 reports · 1991–2026
- BOOK 1,827,009 reports
- RANK #3 of 1000
- DEATH 1,751 death-typed
- INJ 24,185 injury-typed
- MALF 1,798,832 malfunction
- SPAN 1991–2026
- PEAK 2022: 888,020
- PHOTO Integrated Continuous…
Nearest event-volume peer: Integrated Continuous Glucose Monitoring System, Factory Calibrated (347,186 report gap)
Pump, Infusion sits #3 of 1000 among tracked device types with 1,827,009 MAUDE reports spanning 1991–2026. 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 →
Malfunction reports run above the device-type norm
Pump, Infusion carries 98.5% MALFUNCTION-coded reports, 33.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
- INJ 1.3% corpus 30.3% · below corpus mean (-29.0 pp)
- MALF 98.5% corpus 64.8% · above corpus mean (+33.6 pp)
Lead product-problem code Crack is 41% of coded problems · Lead manufacturer CAREFUSION SD accounts for 80% of manufacturer-tagged reports · Top event location is 86% of location-tagged rows .
Pump, Infusion in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Integrated Co…
Integrated Continuous Glucose Monitoring System, Factory Calibrated
2,174,195 reports
- Pump, Infusion (this)
Pump, Infusion
1,827,009 reports
- Alternate Con…
Alternate Controller Enabled Insulin Infusion Pump
1,260,826 reports
- Pump
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
890,539 reports
- Automated Ins…
Automated Insulin Dosing Device System, Single Hormonal Control
885,752 reports
- Pump 539,077
Pump, Infusion, Insulin
539,077 reports
What this shows Pump, Infusion carries 1,827,009 MAUDE reports, ranked #3 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports fell to 53,486 in 2025, down from an average of 111,785 in the two years before.
Related Entities for Pump, Infusion
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Pump, Infusion: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (1,827,009 here).
Similar death-typed counts
Nearest other device types by death-typed report count (1,751 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Pump, Infusion 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 Pump, Infusion; 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.