Pump, Infusion, Enteral
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, Enteral MID-BOOK · MAUDE
#173 of 1000 · 14,912 reports · 1992–2026
- BOOK 14,912 reports
- RANK #173 of 1000
- DEATH 85 death-typed
- INJ 393 injury-typed
- MALF 14,246 malfunction
- SPAN 1992–2026
- PEAK 2017: 2,620
- PHOTO Tube Tracheostomy And…
Nearest event-volume peer: Tube Tracheostomy And Tube Cuff (15 report gap)
Pump, Infusion, Enteral sits #173 of 1000 among tracked device types with 14,912 MAUDE reports spanning 1992–2026. 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, Enteral carries 95.5% MALFUNCTION-coded reports, 30.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.6% corpus 1.5% · below corpus mean (-0.9 pp)
- INJ 2.6% corpus 30.3% · below corpus mean (-27.7 pp)
- MALF 95.5% corpus 64.8% · above corpus mean (+30.7 pp)
Lead product-problem code Fluid/Blood Leak is 14% of coded problems · Lead manufacturer COVIDIEN accounts for 65% of manufacturer-tagged reports · Top event location I is 58% of location-tagged rows .
Pump, Infusion, Enteral in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Tube Tracheos…
Tube Tracheostomy And Tube Cuff
14,927 reports
- Pump (this)
Pump, Infusion, Enteral
14,912 reports
- Lift
Lift, Patient, Non-Ac-Powered
14,697 reports
- Appliance
Appliance, Fixation, Spinal Interlaminal
14,567 reports
- Pulse Generat…
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
14,494 reports
- Device
Device, Vascular, For Promoting Embolization
14,423 reports
What this shows Pump, Infusion, Enteral carries 14,912 MAUDE reports, ranked #173 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 in 2025 (378) held close to the prior two-year average of 302.
Related Entities for Pump, Infusion, Enteral
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Pump, Infusion, Enteral: 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 (14,912 here).
Similar death-typed counts
Nearest other device types by death-typed report count (85 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Pump, Infusion, Enteral 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, Enteral; 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.