2026 data FDA MAUDE openFDA

Control, Pump Speed, 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 Control, Pump Speed, Cardiopulmonary Bypass LIGHT-BOOK · MAUDE

#372 of 1000 · 3,354 reports · 1995–2026

  • BOOK 3,354 reports
  • RANK #372 of 1000
  • DEATH 47 death-typed
  • INJ 436 injury-typed
  • MALF 2,695 malfunction
  • SPAN 1995–2026
  • PEAK 2023: 438
  • PHOTO Extractor

Nearest event-volume peer: Extractor (27 report gap)

Control, Pump Speed, Cardiopulmonary Bypass sits #372 of 1000 among tracked device types with 3,354 MAUDE reports spanning 1995–2026. 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 1.4% corpus 1.5% · near corpus mean (-0.1 pp)
  • INJ 13.0% corpus 30.4% · below corpus mean (-17.4 pp)
  • MALF 80.4% corpus 64.5% · above corpus mean (+15.8 pp)

Lead product-problem code Insufficient Information is 13% of coded problems · Lead manufacturer PERFUSION SYSTEMS accounts for 48% of manufacturer-tagged reports · Top event location is 62% of location-tagged rows .

Control, Pump Speed, Cardiopulmonary Bypass in the event-volume neighbourhood

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

reports

What this shows Control, Pump Speed, Cardiopulmonary Bypass carries 3,354 MAUDE reports, ranked #372 of 1000.

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

Event Types

Malfunction 2,695 (80.4%)
Injury 436 (13.0%)
Other 150 (4.5%)
Death 47 (1.4%)
26 (0.8%)

Patient Outcomes

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

2,900 (83.8%)
Required Intervention 231 (6.7%)
R 82 (2.4%)
Other 70 (2.0%)
Hospitalization 61 (1.8%)
Life Threatening 45 (1.3%)
Death 44 (1.3%)
L 12 (0.3%)
O 8 (0.2%)
S 4 (0.1%)
H 3 (0.1%)
D 1 (0.0%)

Top Product Problems

Insufficient Information 350
Battery Problem 299
Pumping Stopped 223
Power Problem 219
Device Alarm System 205
Infusion or Flow Problem 178
Electrical /Electronic Property Problem 142
Mechanical Problem 138
Unexpected Shutdown 113
No Display/Image 107
Pumping Problem 106
Noise, Audible 104
Display or Visual Feedback Problem 99
Communication or Transmission Problem 68
Decreased Pump Speed 66
Overheating of Device 59
Device Displays Incorrect Message 44
No Apparent Adverse Event 42
Obstruction of Flow 39
No Flow 35

Yearly Trend

95
1995: 2
96
1996: 6
97
1997: 14
98
1998: 9
99
1999: 6
00
2000: 6
01
2001: 8
02
2002: 1
04
2004: 9
05
2005: 9
06
2006: 10
07
2007: 10
08
2008: 10
09
2009: 17
10
2010: 110
11
2011: 147
12
2012: 102
13
2013: 100
14
2014: 98
15
2015: 103
16
2016: 109
17
2017: 140
18
2018: 200
19
2019: 376
20
2020: 146
21
2021: 155
22
2022: 205
23
2023: 438
24
2024: 390
25
2025: 366
26
2026: 52

Related Entities for Control, Pump Speed, Cardiopulmonary Bypass

Event Locations

2,085 (62.2%)
I 1,113 (33.2%)
HOSPITAL 124 (3.7%)
NO INFORMATION 26 (0.8%)
OTHER 4 (0.1%)
INVALID DATA 2 (0.1%)

Compare PERFUSION SYSTEMS vs LIVANOVA DEUTSCHLAND →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Control, Pump Speed, 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 (3,354 here).

Similar death-typed counts

Nearest other device types by death-typed report count (47 here), distinct from the volume row.

Disclaimer: MAUDE figures for Control, Pump Speed, 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 Control, Pump Speed, 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.