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2026 data FDA MAUDE openFDA FDA Class II

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).

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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

reports

What this shows Heat-Exchanger, Cardiopulmonary Bypass carries 858 MAUDE reports, ranked #709 of 1000.

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

Event Types

Malfunction 705 (82.2%)
Injury 91 (10.6%)
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.

440 (50.9%)
Required Intervention 351 (40.6%)
Other 50 (5.8%)
Death 7 (0.8%)
Hospitalization 5 (0.6%)
R 3 (0.3%)
L 2 (0.2%)
S 2 (0.2%)
Disability 2 (0.2%)
Life Threatening 2 (0.2%)
H 1 (0.1%)

Top Product Problems

Fluid/Blood Leak 197
Leak/Splash 180
Device Displays Incorrect Message 147
Device Operates Differently Than Expected 47
Replace 45
Other (for use when an appropriate device code cannot be identified) 28
Break 27
Failure to Deliver 19
Loss of Power 19
Air Leak 17
Device Sensing Problem 17
Mechanical Problem 16
No Apparent Adverse Event 16
Insufficient Device Problem Information 15
Infusion or Flow Problem 14
Defective Device 11
Partial Blockage 11
Adverse Event Without Identified Device or Use Problem 10
Device Contamination with Chemical or Other Material 10
Device Issue 10

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: 27

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

MERIT MEDICAL SYSTEMS, INC. 34
MAQUET CARDIOPULMONARY AG 32
TERUMO CARDIOVASCULAR SYSTEMS CORP. 31
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 14

Event Locations

433 (50.5%)
I 316 (36.8%)
HOSPITAL 92 (10.7%)
NO INFORMATION 14 (1.6%)
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 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).

Hammer, Surgical 858 Forceps, Ophthalmic 861 Clamp, Circumcision 862 Instrument, Surgical, Disposable 866

Similar death-typed counts

Nearest other device types by death-typed report count (6 here), distinct from the volume row.

Applicator, Absorbent Tipped, Non-Sterile 6 Cable, Electrode 6 Catheter, Straight 6 Dilator, Catheter, Ureteral 6

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.