2026 data FDA MAUDE openFDA

Reservoir, Blood, 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 Reservoir, Blood, Cardiopulmonary Bypass LIGHT-BOOK · MAUDE

#908 of 1000 · 448 reports · 1992–2026

  • BOOK 448 reports
  • RANK #908 of 1000
  • DEATH 24 death-typed
  • INJ 50 injury-typed
  • MALF 335 malfunction
  • SPAN 1992–2026
  • PEAK 2014: 52
  • PHOTO Cane

Nearest event-volume peer: Cane (1 report gap)

Reservoir, Blood, Cardiopulmonary Bypass sits #908 of 1000 among tracked device types with 448 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 5.4% corpus 1.5% · above corpus mean (+3.8 pp)
  • INJ 11.2% corpus 30.4% · below corpus mean (-19.3 pp)
  • MALF 74.8% corpus 64.5% · above corpus mean (+10.3 pp)

Lead product-problem code Air/Gas in Device is 20% of coded problems · Lead manufacturer TERUMO CARDIOVASCULAR SYSTEMS CORP. accounts for 38% of manufacturer-tagged reports · Top event location HOSPITAL is 49% of location-tagged rows .

Reservoir, Blood, Cardiopulmonary Bypass in the event-volume neighbourhood

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

reports

What this shows Reservoir, Blood, Cardiopulmonary Bypass carries 448 MAUDE reports, ranked #908 of 1000.

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

Event Types

Malfunction 335 (74.8%)
Injury 50 (11.2%)
Other 31 (6.9%)
Death 24 (5.4%)
8 (1.8%)

Patient Outcomes

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

266 (58.0%)
Other 89 (19.4%)
Required Intervention 64 (13.9%)
Death 23 (5.0%)
R 7 (1.5%)
Life Threatening 6 (1.3%)
H 1 (0.2%)
O 1 (0.2%)
S 1 (0.2%)
Hospitalization 1 (0.2%)

Top Product Problems

Air/Gas in Device 16
Delivered as Unsterile Product 10
Obstruction of Flow 10
Gas/Air Leak 6
Fluid/Blood Leak 5
Collapse 3
Defective Component 3
Device Dislodged or Dislocated 3
Disconnection 3
Infusion or Flow Problem 3
Pressure Problem 3
Adverse Event Without Identified Device or Use Problem 2
Detachment Of Device Component 2
Detachment of Device or Device Component 2
Filtration Problem 2
Leak/Splash 2
Misassembled 2
Nonstandard Device 2
Air Leak 1
Break 1

Yearly Trend

92
1992: 1
93
1993: 1
94
1994: 1
95
1995: 3
96
1996: 7
97
1997: 24
98
1998: 17
99
1999: 7
00
2000: 14
01
2001: 14
02
2002: 9
03
2003: 11
04
2004: 19
05
2005: 23
06
2006: 10
07
2007: 10
08
2008: 8
09
2009: 10
10
2010: 18
11
2011: 10
12
2012: 17
13
2013: 47
14
2014: 52
15
2015: 27
16
2016: 6
17
2017: 3
18
2018: 4
19
2019: 11
20
2020: 6
21
2021: 12
22
2022: 7
23
2023: 8
24
2024: 10
25
2025: 8
26
2026: 13

Related Entities for Reservoir, Blood, Cardiopulmonary Bypass

Event Locations

HOSPITAL 221 (49.3%)
169 (37.7%)
I 40 (8.9%)
NO INFORMATION 9 (2.0%)
INVALID DATA 7 (1.6%)
UNKNOWN 2 (0.4%)

Compare TERUMO CARDIOVASCULAR SYSTEMS CORP. vs MAQUET CARDIOPULMONARY AG →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Reservoir, Blood, 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 (448 here).

Similar death-typed counts

Nearest other device types by death-typed report count (24 here), distinct from the volume row.

Disclaimer: MAUDE figures for Reservoir, Blood, 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 Reservoir, Blood, 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.