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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book Pump LIGHT-BOOK · MAUDE

#343 of 1000 · 4,251 reports · 1992–2026

  • BOOK 4,251 reports
  • RANK #343 of 1000
  • DEATH 251 death-typed
  • INJ 751 injury-typed
  • MALF 3,172 malfunction
  • SPAN 1992–2026
  • PEAK 2021: 446
  • PHOTO Battery

Nearest event-volume peer: Battery, Replacement, Rechargeable (0 report gap)

Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type sits #343 of 1000 among tracked device types with 4,251 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 5.9% corpus 1.5% · above corpus mean (+4.4 pp)
  • INJ 17.7% corpus 30.4% · below corpus mean (-12.8 pp)
  • MALF 74.6% corpus 64.5% · above corpus mean (+10.1 pp)

Lead product-problem code Electrical /Electronic Property Problem is 19% of coded problems · Lead manufacturer MAQUET CARDIOPULMONARY GMBH accounts for 45% of manufacturer-tagged reports · Top event location is 43% 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 4,251 MAUDE reports, ranked #343 of 1000.

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

Event Types

Malfunction 3,172 (74.6%)
Injury 751 (17.7%)
Death 251 (5.9%)
52 (1.2%)
Other 25 (0.6%)

Patient Outcomes

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

2,959 (65.2%)
Required Intervention 676 (14.9%)
Death 251 (5.5%)
R 175 (3.9%)
Other 161 (3.6%)
Hospitalization 127 (2.8%)
Life Threatening 62 (1.4%)
H 47 (1.0%)
L 41 (0.9%)
O 16 (0.4%)
D 11 (0.2%)
S 4 (0.1%)
Disability 3 (0.1%)
Congenital Anomaly 2 (0.0%)

Top Product Problems

Electrical /Electronic Property Problem 531
Noise, Audible 338
Pumping Stopped 273
Insufficient Information 272
Adverse Event Without Identified Device or Use Problem 205
Mechanical Problem 170
Infusion or Flow Problem 165
Device Displays Incorrect Message 136
Battery Problem 124
Overheating of Device 123
Unexpected Shutdown 87
Communication or Transmission Problem 57
Pumping Problem 52
Inaccurate Flow Rate 48
Fluid/Blood Leak 44
No Display/Image 37
Crack 35
Decreased Pump Speed 32
No Flow 30
Break 29

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: 41

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

Top Manufacturers

MAQUET CARDIOPULMONARY GMBH 1,103
TERUMO CARDIOVASCULAR SYSTEMS CORP. 505
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 351
MAQUET CARDIOPULMONARY AG 333
LIVANOVA DEUTSCHLAND 70
PERFUSION SYSTEMS 66

Event Locations

1,825 (42.9%)
I 1,463 (34.4%)
HOSPITAL 899 (21.1%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Pump, 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 (4,251 here).

Battery, Replacement, Rechargeable 4,251 Pack, Hot Or Cold, Disposable 4,263 System, Hypothermia, Intravenous, Cooling 4,279 Computer, Diagnostic, Programmable 4,214

Similar death-typed counts

Nearest other device types by death-typed report count (251 here), distinct from the volume row.

Bed, Manual 249 Tube, Tracheal 254 Agent, Injectable, Embolic 247 Console 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.