Tubing, Pump, 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 §870.4390 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book Tubing, Pump, Cardiopulmonary Bypass LIGHT-BOOK · MAUDE
#514 of 1000 · 1,866 reports · 1992–2026
- BOOK 1,866 reports
- RANK #514 of 1000
- DEATH 81 death-typed
- INJ 188 injury-typed
- MALF 1,574 malfunction
- SPAN 1992–2026
- PEAK 2023: 286
- PHOTO Bed
Nearest event-volume peer: Bed, Therapeutic, Ac-Powered, Adjustable Home-Use (1 report gap)
Tubing, Pump, Cardiopulmonary Bypass sits #514 of 1000 among tracked device types with 1,866 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
Tubing, Pump, Cardiopulmonary Bypass carries 10.1% INJURY-coded reports, 20.2pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 4.3% corpus 1.5% · above corpus mean (+2.8 pp)
- INJ 10.1% corpus 30.3% · below corpus mean (-20.2 pp)
- MALF 84.4% corpus 64.8% · above corpus mean (+19.5 pp)
Lead product-problem code Fluid/Blood Leak is 33% of coded problems · Lead manufacturer MEDTRONIC MEXICO accounts for 38% of manufacturer-tagged reports · Top event location is 56% of location-tagged rows .
Tubing, Pump, Cardiopulmonary Bypass in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Sterilant
Sterilant, Medical Devices
1,870 reports
- Bed
Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
1,867 reports
- Tubing (this)
Tubing, Pump, Cardiopulmonary Bypass
1,866 reports
- Disinfectant
Disinfectant, Medical Devices
1,864 reports
- Catheter
Catheter, Intracardiac Mapping, High-Density Array
1,863 reports
- Marker
Marker, Radiographic, Implantable
1,851 reports
What this shows Tubing, Pump, Cardiopulmonary Bypass carries 1,866 MAUDE reports, ranked #514 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 fell to 82 in 2025, down from an average of 254 in the two years before.
Related Entities for Tubing, Pump, Cardiopulmonary Bypass
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Tubing, Pump, 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 (1,866 here).
Similar death-typed counts
Nearest other device types by death-typed report count (81 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Tubing, Pump, 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 Tubing, Pump, 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.