Pump, Blood, Cardiopulmonary Bypass, Roller Type
FDA adverse event reports and recall history for pump, blood, cardiopulmonary bypass, roller type (product code DWB), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,832
- Deaths
- 26
- Injuries
- 58
- Malfunctions
- 1,566
Reports per year
Source: FDA adverse event reports by year received, 2011–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2011-11-29TerminatedEmployee error
Battery Module for Sarns Modular Perfusion System 8000 Product Usage: The Sarns Modular Perfusion System 8000 is indicated for up to 6 hours use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist.
Terumo Cardiovascular Systems is aware on one instance in which an incorrectly labeled printed circuit board for the Sarns Modular Perfusion System 8000 was shipped to a single customer. The affected board mislabeled two connection between the board and the transformer.
- 2011-09-15TerminatedComponent change control
Sarns 8000 Cardioplegia Monitor, Catalog Number 16414; also known as PROG COMP BD AMPRO 420 CPG 8K, Catalog Number 816373 The Sarns 8000 Cardioplegia Monitor is indicated to measure extracorporeal line pressure and signal when the pressure exceeds the operator-set limit.
The Cardioplegia Monitor for the Sarns Modular Perfusion System 8000 may fail to track cardioplegia delivery volume.
Monitor pump, blood, cardiopulmonary bypass, roller type automatically
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