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2025 data FDA MAUDE openFDA FDA Class II

Pump, Blood, Cardiopulmonary Bypass, 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 §870.4370 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book Pump LIGHT-BOOK · MAUDE

#520 of 1000 · 1,832 reports · 1993–2025

  • BOOK 1,832 reports
  • RANK #520 of 1000
  • DEATH 26 death-typed
  • INJ 58 injury-typed
  • MALF 1,566 malfunction
  • SPAN 1993–2025
  • PEAK 2017: 361
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Nephrostomy, General & Plastic Surgery (3 report gap)

Pump, Blood, Cardiopulmonary Bypass, Roller Type sits #520 of 1000 among tracked device types with 1,832 MAUDE reports spanning 1993–2025. 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 3.2% INJURY-coded reports, 27.1pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.4% corpus 1.5% · near corpus mean (-0.1 pp)
  • INJ 3.2% corpus 30.3% · below corpus mean (-27.1 pp)
  • MALF 85.5% corpus 64.8% · above corpus mean (+20.7 pp)

Lead product-problem code Pumping Stopped is 23% of coded problems · Lead manufacturer LIVANOVA DEUTSCHLAND accounts for 64% of manufacturer-tagged reports · Top event location I is 71% 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, Roller Type carries 1,832 MAUDE reports, ranked #520 of 1000.

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

Event Types

Malfunction 1,566 (85.5%)
127 (6.9%)
Injury 58 (3.2%)
Other 55 (3.0%)
Death 26 (1.4%)

Patient Outcomes

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

1,692 (91.5%)
Required Intervention 59 (3.2%)
Death 26 (1.4%)
Other 26 (1.4%)
Life Threatening 16 (0.9%)
R 13 (0.7%)
Hospitalization 6 (0.3%)
L 3 (0.2%)
Disability 3 (0.2%)
O 2 (0.1%)
S 2 (0.1%)
Congenital Anomaly 2 (0.1%)

Top Product Problems

Pumping Stopped 399
Device Displays Incorrect Message 322
No Display/Image 290
Pumping Problem 128
Device Operates Differently Than Expected 85
Failure to Pump 79
Appropriate Device Problem Term/Code Not Available 60
Device Operational Issue 59
Display or Visual Feedback Problem 49
Other (for use when an appropriate device code cannot be identified) 44
Break 34
Failure to Power Up 34
Replace 29
Loss of Power 27
Device Stops Intermittently 25
Failure to Auto Stop 25
Mechanical Problem 22
Mechanical Jam 21
Decreased Pump Speed 19
Device Alarm System 17

Yearly Trend

93
1993: 2
94
1994: 3
95
1995: 6
96
1996: 8
97
1997: 16
98
1998: 19
99
1999: 12
00
2000: 9
01
2001: 2
02
2002: 3
03
2003: 3
04
2004: 5
05
2005: 17
06
2006: 11
07
2007: 11
08
2008: 11
09
2009: 5
10
2010: 14
11
2011: 11
12
2012: 27
13
2013: 47
14
2014: 63
15
2015: 122
16
2016: 318
17
2017: 361
18
2018: 258
19
2019: 155
20
2020: 79
21
2021: 58
22
2022: 87
23
2023: 49
24
2024: 39
25
2025: 1

Reports fell to 39 in 2024, down from an average of 68 in the two years before.

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

Top Manufacturers

LIVANOVA DEUTSCHLAND 793
TERUMO CARDIOVASCULAR SYSTEMS CORP. 255
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 168
TERUMO CARDIOVASCULAR SYSTEMS CORP 16

Event Locations

I 1,300 (71.0%)
424 (23.1%)
HOSPITAL 94 (5.1%)
NO INFORMATION 10 (0.5%)
INVALID DATA 3 (0.2%)
OTHER 1 (0.1%)

Compare LIVANOVA DEUTSCHLAND 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 (1,832 here).

Catheter 1,835 Set, Blood Transfusion 1,836 Marker, Radiographic, Implantable 1,851 Generator, Lesion, Radiofrequency 1,812

Similar death-typed counts

Nearest other device types by death-typed report count (26 here), distinct from the volume row.

Catheter 26 Catheter, Irrigation 26 Agent 27 Aid, Transfer 25

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.