Pump, Infusion, Pca
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, Pca MID-BOOK · MAUDE
#102 of 1000 · 32,663 reports · 1992–2026
- BOOK 32,663 reports
- RANK #102 of 1000
- DEATH 225 death-typed
- INJ 861 injury-typed
- MALF 31,207 malfunction
- SPAN 1992–2026
- PEAK 2022: 6,443
- PHOTO Prosthesis
Nearest event-volume peer: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented (11 report gap)
Pump, Infusion, Pca sits #102 of 1000 among tracked device types with 32,663 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, Pca 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 0.7% corpus 1.5% · below corpus mean (-0.8 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 Break is 16% of coded problems · Lead manufacturer CAREFUSION SD accounts for 57% of manufacturer-tagged reports · Top event location is 80% of location-tagged rows .
Pump, Infusion, Pca in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Pump
Pump, Infusion, Elastomeric
33,422 reports
- Detector And…
Detector And Alarm, Arrhythmia
33,370 reports
- Pump (this)
Pump, Infusion, Pca
32,663 reports
- Prosthesis
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
32,652 reports
- Protector
Protector, Ostomy
32,254 reports
- Monitor
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
32,228 reports
What this shows Pump, Infusion, Pca carries 32,663 MAUDE reports, ranked #102 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 (3,330) held close to the prior two-year average of 4,272.
Related Entities for Pump, Infusion, Pca
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Pump, Infusion, Pca: 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 (32,663 here).
Similar death-typed counts
Nearest other device types by death-typed report count (225 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Pump, Infusion, Pca 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, Pca; 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.