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2026 data FDA MAUDE openFDA FDA Class II

Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

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 §870.4360 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book Pump LIGHT-BOOK · MAUDE

#346 of 1000 · 4,355 reports · 1992–2026

  • BOOK 4,355 reports
  • RANK #346 of 1000
  • DEATH 253 death-typed
  • INJ 764 injury-typed
  • MALF 3,261 malfunction
  • SPAN 1992–2026
  • PEAK 2021: 446
  • PHOTO Implant, Eye Valve

Nearest event-volume peer: Implant, Eye Valve (24 report gap)

Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type sits #346 of 1000 among tracked device types with 4,355 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

Pump carries 17.5% INJURY-coded reports, 12.7pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 5.8% corpus 1.5% · above corpus mean (+4.3 pp)
  • INJ 17.5% corpus 30.3% · below corpus mean (-12.7 pp)
  • MALF 74.9% corpus 64.8% · above corpus mean (+10.1 pp)

Lead product-problem code Electrical /Electronic Property Problem is 14% of coded problems · Lead manufacturer MAQUET CARDIOPULMONARY GMBH accounts for 46% of manufacturer-tagged reports · Top event location is 44% of location-tagged rows .

Pump in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type carries 4,355 MAUDE reports, ranked #346 of 1000.

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

Event Types

Malfunction 3,261 (74.9%)
Injury 764 (17.5%)
Death 253 (5.8%)
52 (1.2%)
Other 25 (0.6%)

Patient Outcomes

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

3,037 (65.5%)
Required Intervention 694 (15.0%)
Death 252 (5.4%)
R 177 (3.8%)
Other 163 (3.5%)
Hospitalization 129 (2.8%)
Life Threatening 62 (1.3%)
H 48 (1.0%)
L 41 (0.9%)
O 16 (0.3%)
D 12 (0.3%)
S 4 (0.1%)
Disability 3 (0.1%)
Congenital Anomaly 2 (0.0%)

Top Product Problems

Electrical /Electronic Property Problem 575
Noise, Audible 473
Pumping Stopped 425
Device Displays Incorrect Message 312
Insufficient Device Problem Information 305
Adverse Event Without Identified Device or Use Problem 228
Mechanical Problem 195
Infusion or Flow Problem 189
Battery Problem 183
Leak/Splash 166
Fluid/Blood Leak 154
Overheating of Device 146
Pumping Problem 143
Replace 102
Unexpected Shutdown 88
Device Operates Differently Than Expected 87
Crack 72
No Display/Image 60
Communication or Transmission Problem 58
Break 56

Yearly Trend

92
1992: 1
93
1993: 1
95
1995: 2
96
1996: 9
97
1997: 20
98
1998: 32
99
1999: 14
00
2000: 4
01
2001: 12
02
2002: 21
03
2003: 12
04
2004: 18
05
2005: 27
06
2006: 26
07
2007: 60
08
2008: 62
09
2009: 85
10
2010: 81
11
2011: 57
12
2012: 82
13
2013: 104
14
2014: 347
15
2015: 299
16
2016: 156
17
2017: 121
18
2018: 176
19
2019: 311
20
2020: 437
21
2021: 446
22
2022: 294
23
2023: 346
24
2024: 296
25
2025: 251
26
2026: 145

Reports in 2025 (251) held close to the prior two-year average of 321.

Related Entities for Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

Top Manufacturers

MAQUET CARDIOPULMONARY GMBH 1,152
TERUMO CARDIOVASCULAR SYSTEMS CORP. 505
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 351
MAQUET CARDIOPULMONARY AG 333
LIVANOVA DEUTSCHLAND 70
PERFUSION SYSTEMS 68

Event Locations

1,929 (44.3%)
I 1,463 (33.6%)
HOSPITAL 899 (20.6%)
NO INFORMATION 44 (1.0%)
INVALID DATA 12 (0.3%)
OTHER 4 (0.1%)
HOME 2 (0.0%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
OPERATING ROOM 1 (0.0%)

Compare MAQUET CARDIOPULMONARY GMBH vs TERUMO CARDIOVASCULAR SYSTEMS CORP. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Pump: 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 (4,355 here).

Implant, Eye Valve 4,379 Intestinal Stimulator 4,382 System, Hypothermia, Intravenous, Cooling 4,389 Orthosis, Spondylolisthesis Spinal Fixation 4,392

Similar death-typed counts

Nearest other device types by death-typed report count (253 here), distinct from the volume row.

Bed, Manual 251 Catheter, Steerable 251 Prosthesis 255 Mesh 256

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Pump 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 Pump; 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.