Heat-Exchanger, 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 Class II (moderate risk, special controls required), regulated under 21 CFR §870.4240 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book Heat-Exchanger, Cardiopulmonary Bypass LIGHT-BOOK · MAUDE
#709 of 1000 · 858 reports · 1992–2026
- BOOK 858 reports
- RANK #709 of 1000
- DEATH 6 death-typed
- INJ 91 injury-typed
- MALF 705 malfunction
- SPAN 1992–2026
- PEAK 2015: 96
- PHOTO Hammer, Surgical
Nearest event-volume peer: Hammer, Surgical (0 report gap)
Heat-Exchanger, Cardiopulmonary Bypass sits #709 of 1000 among tracked device types with 858 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 →
Injury-coded reports sit below the device-type norm
Heat-Exchanger, Cardiopulmonary Bypass carries 10.6% INJURY-coded reports, 19.7pp below 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 10.6% corpus 30.3% · below corpus mean (-19.7 pp)
- MALF 82.2% corpus 64.8% · above corpus mean (+17.3 pp)
Lead product-problem code Fluid/Blood Leak is 23% of coded problems · Lead manufacturer MERIT MEDICAL SYSTEMS, INC. accounts for 31% of manufacturer-tagged reports · Top event location is 50% of location-tagged rows .
Heat-Exchanger, Cardiopulmonary Bypass in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Instrument
Instrument, Surgical, Disposable
866 reports
- Clamp
Clamp, Circumcision
862 reports
- Forceps
Forceps, Ophthalmic
861 reports
- Heat-Exchanger (this)
Heat-Exchanger, Cardiopulmonary Bypass
858 reports
- Hammer
Hammer, Surgical
858 reports
- Tubing
Tubing, Fluid Delivery
850 reports
What this shows Heat-Exchanger, Cardiopulmonary Bypass carries 858 MAUDE reports, ranked #709 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 rose to 44 in 2025, up from an average of 13 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Heat-Exchanger, Cardiopulmonary Bypass
Top Manufacturers
Event Locations
Compare MERIT MEDICAL SYSTEMS, INC. vs MAQUET CARDIOPULMONARY AG →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Heat-Exchanger, Cardiopulmonary Bypass: 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 (858 here).
Similar death-typed counts
Nearest other device types by death-typed report count (6 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Heat-Exchanger, 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 Heat-Exchanger, 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.