2026 data FDA MAUDE openFDA

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

reports

What this shows Heat-Exchanger, Cardiopulmonary Bypass carries 845 MAUDE reports, ranked #695 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 698 (82.6%)
Injury 85 (10.1%)
Other 34 (4.0%)
22 (2.6%)
Death 6 (0.7%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

436 (51.4%)
Required Intervention 345 (40.6%)
Other 44 (5.2%)
Death 7 (0.8%)
Hospitalization 5 (0.6%)
R 3 (0.4%)
L 2 (0.2%)
S 2 (0.2%)
Disability 2 (0.2%)
Life Threatening 2 (0.2%)
H 1 (0.1%)

Top Product Problems

Device Displays Incorrect Message 93
Fluid/Blood Leak 80
Leak/Splash 31
Device Operates Differently Than Expected 27
Device Sensing Problem 17
Mechanical Problem 14
Infusion or Flow Problem 13
Insufficient Information 13
No Apparent Adverse Event 12
Loss of Power 11
Adverse Event Without Identified Device or Use Problem 9
Air Leak 9
Failure to Deliver 9
Defective Device 8
Improper Flow or Infusion 8
Appropriate Term/Code Not Available 7
Solder Joint Fracture 7
Defective Component 6
Device Contamination with Chemical or Other Material 6
Gas/Air Leak 6

Yearly Trend

92
1992: 1
94
1994: 1
96
1996: 2
98
1998: 3
99
1999: 3
00
2000: 6
01
2001: 3
02
2002: 5
03
2003: 35
04
2004: 11
05
2005: 7
06
2006: 60
07
2007: 2
08
2008: 1
10
2010: 43
11
2011: 67
12
2012: 16
13
2013: 27
14
2014: 66
15
2015: 96
16
2016: 60
17
2017: 69
18
2018: 75
19
2019: 35
20
2020: 33
21
2021: 11
22
2022: 23
23
2023: 18
24
2024: 8
25
2025: 44
26
2026: 14

Related Entities for Heat-Exchanger, Cardiopulmonary Bypass

Event Locations

425 (50.3%)
I 316 (37.4%)
HOSPITAL 87 (10.3%)
NO INFORMATION 14 (1.7%)
INVALID DATA 1 (0.1%)
NURSING HOME 1 (0.1%)
OTHER 1 (0.1%)

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.

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.