Control, Pump Speed, 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 §870.4380 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book Control, Pump Speed, Cardiopulmonary Bypass LIGHT-BOOK · MAUDE
#374 of 1000 · 3,469 reports · 1995–2026
- BOOK 3,469 reports
- RANK #374 of 1000
- DEATH 48 death-typed
- INJ 440 injury-typed
- MALF 2,805 malfunction
- SPAN 1995–2026
- PEAK 2023: 438
- PHOTO Catheters
Nearest event-volume peer: Catheters, Suction, Tracheobronchial (12 report gap)
Control, Pump Speed, Cardiopulmonary Bypass sits #374 of 1000 among tracked device types with 3,469 MAUDE reports spanning 1995–2026. 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
Control, Pump Speed, Cardiopulmonary Bypass carries 12.7% INJURY-coded reports, 17.6pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 1.4% corpus 1.5% · near corpus mean (-0.1 pp)
- INJ 12.7% corpus 30.3% · below corpus mean (-17.6 pp)
- MALF 80.9% corpus 64.8% · above corpus mean (+16.0 pp)
Lead product-problem code Insufficient Device Problem Information is 12% of coded problems · Lead manufacturer PERFUSION SYSTEMS accounts for 49% of manufacturer-tagged reports · Top event location is 63% of location-tagged rows .
Control, Pump Speed, Cardiopulmonary Bypass in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Extractor
Extractor
3,487 reports
- Stimulator
Stimulator, Hypoglossal Nerve, Implanted, Apnea
3,486 reports
- Control (this)
Control, Pump Speed, Cardiopulmonary Bypass
3,469 reports
- Catheters
Catheters, Suction, Tracheobronchial
3,457 reports
- Gauge, Depth
Gauge, Depth
3,439 reports
- Active Implan…
Active Implantable Bone Conduction Hearing System
3,437 reports
What this shows Control, Pump Speed, Cardiopulmonary Bypass carries 3,469 MAUDE reports, ranked #374 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 (366) held close to the prior two-year average of 414.
Related Entities for Control, Pump Speed, Cardiopulmonary Bypass
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Control, Pump Speed, 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 (3,469 here).
Similar death-typed counts
Nearest other device types by death-typed report count (48 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Control, Pump Speed, 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 Control, Pump Speed, 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.