Pump, Blood, Cardiopulmonary Bypass, Roller Type
Cardiovascular · 21 CFR 870.4370
Recent MDR events
1,832 adverse event reports on file
- S5 ROLLER PUMP 150Sep 19, 2025MalfunctionLivanova Deutschland9611109-2025-90376
- QUANTUM ROLLER PUMPDec 4, 2024MalfunctionSpectrum Medical Limited3006073153-2024-00122
- QUANTUM ROLLER PUMPAug 8, 2024MalfunctionSpectrum Medical Limited3006073153-2024-00036
- QUANTUM ROLLER PUMPAug 8, 2024MalfunctionSpectrum Medical Limited3006073153-2024-00037
- S5 MAST ROLLER PUMPAug 2, 2024MalfunctionLivanova Deutschland9611109-2024-00348
- QUANTUM ROLLER PUMPJul 30, 2024MalfunctionSpectrum Medical Limited3006073153-2024-00027
- S5 DOUBLE HEAD PUMPJul 26, 2024MalfunctionLivanova Deutschland9611109-2024-00331
- S5 MAST ROLLER PUMPJul 9, 2024MalfunctionLivanova Deutschland9611109-2024-00297
- S5 ROLLER PUMPJul 9, 2024MalfunctionLivanova Deutschland9611109-2024-00298
- S5 DOUBLE HEAD PUMPJul 9, 2024MalfunctionLivanova Deutschland9611109-2024-00300
Event type breakdown
Recalls
2 recall events for this product code
- Terumo Cardiovascular Systems CorporationTerminatedNov 29, 2011
Battery Module for Sarns Modular Perfusion System 8000
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.
Z-0303-2012 · View FDA record ↗ - Terumo Cardiovascular Systems CorporationTerminatedSep 15, 2011
Sarns 8000 Cardioplegia Monitor, Catalog Number 16414; also known as PROG COMP BD AMPRO 420 CPG 8K, Catalog Number 816373
The Cardioplegia Monitor for the Sarns Modular Perfusion System 8000 may fail to track cardioplegia delivery volume.
Z-3214-2011 · View FDA record ↗
Registered firms
9 firms currently registered for this product code
510(k) clearances
21 clearances for this product code
- Terumo Cardiovascular Systems CorporationNov 17, 2016
K162843 · Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1
- Terumo Cardiovascular Systems CorporationSep 27, 2013
K131618 · LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYST
- Terumo Cardiovascular Systems Corp.Dec 19, 2011
K112587 · ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,
- Medtronic Bio-Medicus, Inc.Apr 27, 1998
K973237 · CSS-CARDIOPLEGIA SAFETY SYSTEM
- Stoeckert InstrumenteFeb 27, 1998
K972321 · S3 MAST PUMP
- Stoeckert InstrumenteSep 10, 1997
K971520 · S3 CYCLIC RPM CONTROL
- Cobe Cardiovascular, Inc.Jul 14, 1997
K960974 · COBE CENTURY PERFUSION PUMP
- 3M Health Care, Ltd.Apr 19, 1996
K953904 · SARNS 9000 UNIVERSAL ROLLER PUMP