PlainHospital
2025 data FDA MAUDE openFDA

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.

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Pump LIGHT-BOOK · MAUDE

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

  • BOOK 1,832 reports
  • RANK #505 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 (5 report gap)

Pump, Blood, Cardiopulmonary Bypass, Roller Type sits #505 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 →

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 3.2% corpus 30.4% · below corpus mean (-27.3 pp)
  • MALF 85.5% corpus 64.5% · above corpus mean (+21.0 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 #505 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 321
Device Displays Incorrect Message 261
No Display/Image 255
Pumping Problem 125
Appropriate Term/Code Not Available 60
Device Operational Issue 53
Failure to Pump 48
Display or Visual Feedback Problem 45
Device Operates Differently Than Expected 44
Failure to Power Up 29
Failure to Auto Stop 25
Mechanical Jam 19
Break 17
Mechanical Problem 16
Detachment Of Device Component 15
Fracture 15
Output Problem 14
Device Stops Intermittently 13
Decreased Pump Speed 12
Loss of Power 11

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

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 1,301 (71.0%)
423 (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 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 (1,832 here).

Catheter 1,827 Radioimmunoassay, Free Thyroxine 1,849 Tubing, Pump, Cardiopulmonary Bypass 1,852 Disinfectant, Medical Devices 1,854

Similar death-typed counts

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

Biopsy Needle 26 Catheter 26 Catheter, Irrigation 26 Stimulator 26

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.