Oxygenator, Cardiopulmonary Bypass
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 MAUDE casebook
openFDA event book Oxygenator, Cardiopulmonary Bypass LIGHT-BOOK · MAUDE
#216 of 1000 · 9,642 reports · 1992–2026
- BOOK 9,642 reports
- RANK #216 of 1000
- DEATH 445 death-typed
- INJ 1,495 injury-typed
- MALF 7,372 malfunction
- SPAN 1992–2026
- PEAK 2025: 987
- PHOTO Walker, Mechanical
Nearest event-volume peer: Walker, Mechanical (54 report gap)
Oxygenator, Cardiopulmonary Bypass sits #216 of 1000 among tracked device types with 9,642 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 →
Event-type mix vs corpus
Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.
- DEATH 4.6% corpus 1.5% · above corpus mean (+3.1 pp)
- INJ 15.5% corpus 30.4% · below corpus mean (-14.9 pp)
- MALF 76.5% corpus 64.5% · above corpus mean (+12.0 pp)
Lead product-problem code Fluid/Blood Leak is 25% of coded problems · Lead manufacturer PERFUSION SYSTEMS accounts for 22% of manufacturer-tagged reports · Top event location is 45% of location-tagged rows .
Oxygenator, Cardiopulmonary Bypass in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Appliance
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
9,772 reports
- Saw
Saw, Powered, And Accessories
9,741 reports
- Walker
Walker, Mechanical
9,696 reports
- Oxygenator (this)
Oxygenator, Cardiopulmonary Bypass
9,642 reports
- Keratome
Keratome, Ac-Powered
9,574 reports
- Prosthesis
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
9,486 reports
What this shows Oxygenator, Cardiopulmonary Bypass carries 9,642 MAUDE reports, ranked #216 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
Related Entities for Oxygenator, Cardiopulmonary Bypass
Top Manufacturers
Event Locations
Compare PERFUSION SYSTEMS vs TERUMO CARDIOVASCULAR SYSTEMS CORPORATION →
Nationwide devices with similar MAUDE profiles
Two openFDA-derived peer sets for Oxygenator, Cardiopulmonary Bypass, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (9,642 here).
Similar death-typed counts
Nearest other device types by death-typed report count (445 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Oxygenator, Cardiopulmonary Bypass 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 Oxygenator, Cardiopulmonary Bypass; 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.