2026 data FDA MAUDE openFDA

Tubing, Pump, 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 Tubing, Pump, Cardiopulmonary Bypass LIGHT-BOOK · MAUDE

#503 of 1000 · 1,852 reports · 1992–2026

  • BOOK 1,852 reports
  • RANK #503 of 1000
  • DEATH 81 death-typed
  • INJ 187 injury-typed
  • MALF 1,561 malfunction
  • SPAN 1992–2026
  • PEAK 2023: 286
  • PHOTO Disinfectant

Nearest event-volume peer: Disinfectant, Medical Devices (2 report gap)

Tubing, Pump, Cardiopulmonary Bypass sits #503 of 1000 among tracked device types with 1,852 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 4.4% corpus 1.5% · above corpus mean (+2.9 pp)
  • INJ 10.1% corpus 30.4% · below corpus mean (-20.3 pp)
  • MALF 84.3% corpus 64.5% · above corpus mean (+19.8 pp)

Lead product-problem code Fluid/Blood Leak is 38% of coded problems · Lead manufacturer MEDTRONIC MEXICO accounts for 38% of manufacturer-tagged reports · Top event location is 55% of location-tagged rows .

Tubing, Pump, Cardiopulmonary Bypass in the event-volume neighbourhood

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

reports

What this shows Tubing, Pump, Cardiopulmonary Bypass carries 1,852 MAUDE reports, ranked #503 of 1000.

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

Event Types

Malfunction 1,561 (84.3%)
Injury 187 (10.1%)
Death 81 (4.4%)
Other 21 (1.1%)
2 (0.1%)

Patient Outcomes

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

1,375 (72.4%)
Required Intervention 202 (10.6%)
Other 153 (8.1%)
Death 80 (4.2%)
R 33 (1.7%)
Life Threatening 32 (1.7%)
S 8 (0.4%)
Hospitalization 7 (0.4%)
L 5 (0.3%)
H 3 (0.2%)
O 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Fluid/Blood Leak 470
Device Operates Differently Than Expected 73
Obstruction of Flow 73
Leak/Splash 68
Material Separation 67
Crack 63
Air/Gas in Device 58
Disconnection 57
Material Puncture/Hole 56
Material Deformation 41
Misassembled During Installation 31
Noise, Audible 28
Break 23
Defective Component 22
Increase in Pressure 19
Misassembled 17
Device Displays Incorrect Message 16
No Flow 16
Pressure Problem 16
Adverse Event Without Identified Device or Use Problem 15

Yearly Trend

92
1992: 2
94
1994: 2
95
1995: 8
96
1996: 10
97
1997: 20
98
1998: 8
99
1999: 16
00
2000: 22
01
2001: 16
02
2002: 11
03
2003: 16
04
2004: 27
05
2005: 11
06
2006: 19
07
2007: 10
08
2008: 12
09
2009: 17
10
2010: 20
11
2011: 9
12
2012: 7
13
2013: 21
14
2014: 129
15
2015: 133
16
2016: 151
17
2017: 131
18
2018: 134
19
2019: 82
20
2020: 45
21
2021: 41
22
2022: 123
23
2023: 286
24
2024: 221
25
2025: 83
26
2026: 9

Related Entities for Tubing, Pump, Cardiopulmonary Bypass

Event Locations

1,027 (55.5%)
I 602 (32.5%)
HOSPITAL 179 (9.7%)
NO INFORMATION 26 (1.4%)
INVALID DATA 15 (0.8%)
OTHER 1 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)
UNKNOWN 1 (0.1%)

Compare MEDTRONIC MEXICO vs MAQUET CARDIOPULMONARY AG →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Tubing, Pump, 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 (1,852 here).

Similar death-typed counts

Nearest other device types by death-typed report count (81 here), distinct from the volume row.

Disclaimer: MAUDE figures for Tubing, Pump, 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 Tubing, Pump, 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.