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 MAUDE casebook
openFDA event book Heat-Exchanger, Cardiopulmonary Bypass LIGHT-BOOK · MAUDE
#695 of 1000 · 845 reports · 1992–2026
- BOOK 845 reports
- RANK #695 of 1000
- DEATH 6 death-typed
- INJ 85 injury-typed
- MALF 698 malfunction
- SPAN 1992–2026
- PEAK 2015: 96
- PHOTO Digital Breast Tomosy…
Nearest event-volume peer: Digital Breast Tomosynthesis (1 report gap)
Heat-Exchanger, Cardiopulmonary Bypass sits #695 of 1000 among tracked device types with 845 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 0.7% corpus 1.5% · below corpus mean (-0.8 pp)
- INJ 10.1% corpus 30.4% · below corpus mean (-20.4 pp)
- MALF 82.6% corpus 64.5% · above corpus mean (+18.1 pp)
Lead product-problem code Device Displays Incorrect Message is 24% 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
- Laparoscopic…
Laparoscopic Contraceptive Tubal Occlusion Device
847 reports
- Digital Breas…
Digital Breast Tomosynthesis
846 reports
- Heat-Exchanger (this)
Heat-Exchanger, Cardiopulmonary Bypass
845 reports
- Probe
Probe, Radiofrequency Lesion
844 reports
- Device
Device, Endoscopic Suturing
843 reports
- Plate
Plate, Cranioplasty, Preformed, Alterable
842 reports
What this shows Heat-Exchanger, Cardiopulmonary Bypass carries 845 MAUDE reports, ranked #695 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 Heat-Exchanger, Cardiopulmonary Bypass
Top Manufacturers
Event Locations
Compare MERIT MEDICAL SYSTEMS, INC. vs MAQUET CARDIOPULMONARY AG →
Nationwide devices with similar MAUDE profiles
Two openFDA-derived peer sets for Heat-Exchanger, 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 (845 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.