PlainHospital

MAQUET CARDIOPULMONARY GMBH

Manufacturer adverse-event records for MAQUET CARDIOPULMONARY GMBH come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 2014–2026 · thin-book · elevated Death-code · injury-light

Death-code intensity

MAQUET CARDIOPULMONARY GMBH carries an elevated Death-code share

Death-coded event_type rows are 330 of 4,117 (8.02% · elevated tercile among 443 manufacturers). Absolute volume is thin-book.

What the Death-code reading shows for MAQUET CARDIOPULMONARY GMBH

The standout signal for MAQUET CARDIOPULMONARY GMBH is Death-code intensity: 8.02% of 4,117 reports (elevated tercile), while absolute volume is thin-book.

As a thinner-book manufacturer, a handful of device families can swing the totals; open the device table rather than reading the company headline alone. Event_type counts are not the same population as Patient Outcomes.

Reports span 15 device types, led in this extract by Malfunction at 3,629 (88.1% of event_type total). Peak single-year volume reaches 707 reports across 11 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

4,117
Total Reports
330
Event-type Death
158
Injury Reports
15
Device Types

Event Types

Malfunction 3,629 (88.1%)
Death 330 (8.0%)
Injury 158 (3.8%)

Patient Outcomes

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

3,152 (75.0%)
Required Intervention 386 (9.2%)
Death 315 (7.5%)
Other 164 (3.9%)
Life Threatening 81 (1.9%)
R 58 (1.4%)
L 27 (0.6%)
D 9 (0.2%)
O 5 (0.1%)
Hospitalization 2 (0.0%)
H 1 (0.0%)

Devices (15)

Device Reports
Console, Heart-Lung Machine, Cardiopulmonary Bypass 1,649
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type 1,103
Oxygenator, Cardiopulmonary Bypass 871
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 217
Tubing, Pump, Cardiopulmonary Bypass 134
Controller, Temperature, Cardiopulmonary Bypass 114
Dialyzer, High Permeability With Or Without Sealed Dialysate System 10
Reservoir, Blood, Cardiopulmonary Bypass 8
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass 3
Heat-Exchanger, Cardiopulmonary Bypass 2
System, Balloon, Intra-Aortic And Control 2
Accessory Equipment, Cardiopulmonary Bypass 1
Depressor, Tongue, Non-Surgical 1
Filter, Blood, Cardiopulmonary Bypass, Arterial Line 1
Suction Control, Intracardiac, Cardiopulmonary Bypass 1

Yearly Trend

14
2014: 2
15
2015: 3
16
2016: 1
19
2019: 331
20
2020: 461
21
2021: 707
22
2022: 563
23
2023: 694
24
2024: 642
25
2025: 619
26
2026: 94

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