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2026 data FDA MAUDE openFDA FDA Class II

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 Class II (moderate risk, special controls required), regulated under 21 CFR §870.4400 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book Reservoir, Blood, Cardiopulmonary Bypass LIGHT-BOOK · MAUDE

#901 of 1000 · 490 reports · 1992–2026

  • BOOK 490 reports
  • RANK #901 of 1000
  • DEATH 24 death-typed
  • INJ 50 injury-typed
  • MALF 377 malfunction
  • SPAN 1992–2026
  • PEAK 2026: 55
  • PHOTO Joint

Nearest event-volume peer: Joint, Knee, External Brace (1 report gap)

Reservoir, Blood, Cardiopulmonary Bypass sits #901 of 1000 among tracked device types with 490 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 →

Injury-coded reports sit below the device-type norm

Reservoir, Blood, Cardiopulmonary Bypass carries 10.2% INJURY-coded reports, 20.1pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 4.9% corpus 1.5% · above corpus mean (+3.4 pp)
  • INJ 10.2% corpus 30.3% · below corpus mean (-20.1 pp)
  • MALF 76.9% corpus 64.8% · above corpus mean (+12.1 pp)

Lead product-problem code Leak/Splash is 15% of coded problems · Lead manufacturer TERUMO CARDIOVASCULAR SYSTEMS CORP. accounts for 28% of manufacturer-tagged reports · Top event location HOSPITAL is 45% 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 490 MAUDE reports, ranked #901 of 1000.

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

Event Types

Malfunction 377 (76.9%)
Injury 50 (10.2%)
Other 31 (6.3%)
Death 24 (4.9%)
8 (1.6%)

Patient Outcomes

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

304 (60.8%)
Other 92 (18.4%)
Required Intervention 64 (12.8%)
Death 23 (4.6%)
R 7 (1.4%)
Life Threatening 6 (1.2%)
H 1 (0.2%)
O 1 (0.2%)
S 1 (0.2%)
Hospitalization 1 (0.2%)

Top Product Problems

Leak/Splash 65
Replace 65
Contamination 35
Fluid/Blood Leak 27
Detachment Of Device Component 25
Other (for use when an appropriate device code cannot be identified) 25
Restricted Flow rate 23
Device Damaged Prior to Use 20
Air/Gas in Device 19
Reservoir 16
Component(s), broken 15
Device Issue 15
Obstruction of Flow 14
Air Leak 13
Collapse 13
Delivered as Unsterile Product 11
Infusion or Flow Problem 11
Occlusion Within Device 11
Break 10
Crack 9

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: 55

Reports in 2025 (8) held close to the prior two-year average of 9.

Related Entities for Reservoir, Blood, Cardiopulmonary Bypass

Top Manufacturers

TERUMO CARDIOVASCULAR SYSTEMS CORP. 53
MAQUET CARDIOPULMONARY AG 48
MEDTRONIC MEXICO S. DE R.L. DE CV 44
BAXTER HEALTHCARE CORP. 24
PERFUSION SYSTEMS 18

Event Locations

HOSPITAL 222 (45.3%)
210 (42.9%)
I 40 (8.2%)
NO INFORMATION 9 (1.8%)
INVALID DATA 7 (1.4%)
UNKNOWN 2 (0.4%)

Compare TERUMO CARDIOVASCULAR SYSTEMS CORP. vs MAQUET CARDIOPULMONARY AG →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Reservoir, Blood, Cardiopulmonary Bypass: 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 (490 here).

Joint, Knee, External Brace 489 Blood Pressure Cuff 492 Enzyme Linked Immunoabsorption Assay 492 Prosthesis, Finger, Constrained, Polymer 492

Similar death-typed counts

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

Apparatus, Suction, Patient Care 24 Catheter, Oximeter, Fiber-Optic 24 Chair, Positioning, Electric 24 Laparoscope, Gynecologic 24

Read our methodology - how this data is sourced, computed, and verified.

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.