Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass
Cardiovascular · 21 CFR 870.4340
Recent MDR events
153 adverse event reports on file
- QUANTUM LEVEL SENSOR 2.0M - SINGLE HEADOct 17, 2024MalfunctionSpectrum Medical Limited3006073153-2024-00066
- QUANTUM LEVEL SENSOR 2.0M - SINGLE HEADOct 17, 2024MalfunctionSpectrum Medical Limited3006073153-2024-00067
- BUBBLE SENSOR DETECTORMar 4, 2024MalfunctionLivanova Deutschland9611109-2024-00111
- FLOW SENSOR 3/8"Feb 19, 2024MalfunctionLivanova Deutschland9611109-2024-00081
- SARNS 8000 PERFUSION SYSTEMNov 18, 2021MalfunctionTerumo Cardiovascular Systems Corporation1828100-2021-00430
- SARNS 8000 PERFUSION SYSTEMOct 29, 2021MalfunctionTerumo Cardiovascular Systems Corporation1828100-2021-00391
- SARNS 8000 PERFUSION SYSTEMNov 2, 2020MalfunctionTerumo Cardiovascular Systems Corporation1828100-2020-00419
- S3 BUBB DET SENSOR, LOW LEVEL IIMar 4, 2020MalfunctionLivanova Deutschland Gmbh9611109-2020-00158
- S3 BUBB DET SENSOR, LOW LEVEL IIDec 4, 2019MalfunctionLivanova Deutschland Gmbh9611109-2019-00941
- S3 BUBB DET SENSOR, LOW LEVEL IINov 28, 2019MalfunctionLivanova Deutschland Gmbh9611109-2019-00923
Event type breakdown
Recalls
15 recall events for this product code
- Terumo Cardiovascular Systems CorpTerminatedMar 27, 2007
Terumo Perfusion System 8000 Base, 4 pump, 115v; Model 8000; Catalog No. 16400.
The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cranks recalled in the Summer of 2006.)
Z-0655-2007 · View FDA record ↗ - Terumo Cardiovascular Systems CorpTerminatedMar 27, 2007
Terumo Perfusion System 8000 Base, 5 pump, 115v; Model 8000; Catalog No. 16401.
The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cranks recalled in the Summer of 2006.)
Z-0656-2007 · View FDA record ↗ - Terumo Cardiovascular Systems CorpTerminatedMar 27, 2007
Terumo Perfusion System 8000 Base, 4 pump, 220/240v; Model 8000; Catalog No. 16405.
The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cranks recalled in the Summer of 2006.)
Z-0657-2007 · View FDA record ↗ - Terumo Cardiovascular Systems CorpTerminatedMar 27, 2007
Terumo Perfusion System 8000 Base, 5 pump, 220/240v; Model 8000; Catalog No. 16406.
The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cranks recalled in the Summer of 2006.)
Z-0658-2007 · View FDA record ↗ - Terumo Cardiovascular Systems CorpTerminatedMar 27, 2007
Terumo Perfusion System 8000 Base, 5 pump, 100v, Model 8000; Catalog No. 16410.
The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cranks recalled in the Summer of 2006.)
Z-0659-2007 · View FDA record ↗ - Terumo Cardiovascular Systems CorpTerminatedDec 7, 2006
Terumo Perfusion System 9000, 100v, with color screen; Model 9000; Catalog No. 164280.
The hand crank handle may separate and detach from the unit during use.
Z-0233-2007 · View FDA record ↗ - Terumo Cardiovascular Systems CorpTerminatedDec 7, 2006
Terumo Perfusion System 9000, 220/240v, with color screen; Model 9000; Catalog No. 164290.
The hand crank handle may separate and detach from the unit during use.
Z-0234-2007 · View FDA record ↗ - Terumo Cardiovascular Systems CorpTerminatedDec 7, 2006
Terumo Perfusion System 9000, 115v, with color screen; Model 9000; Catalog No. 164300.
The hand crank handle may separate and detach from the unit during use.
Z-0235-2007 · View FDA record ↗ - Terumo Cardiovascular Systems CorpTerminatedDec 7, 2006
Terumo Perfusion System 8000 Base, 4 pump, 115v; Model 8000; Catalog No. 16400.
The hand crank handle may separate and detach from the unit during use.
Z-0236-2007 · View FDA record ↗ - Terumo Cardiovascular Systems CorpTerminatedDec 7, 2006
Terumo Perfusion System 8000 Base, 5 pump, 115v; Model 8000; Catalog No. 16401.
The hand crank handle may separate and detach from the unit during use.
Z-0237-2007 · View FDA record ↗
Registered firms
6 firms currently registered for this product code
510(k) clearances
17 clearances for this product code
- Medtronic, Inc.May 8, 2015
K150530 · Level Sensor, Level Sensor Tape
- Stockert Instrumente GmbHJul 2, 2004
K041558 · STOCKERTIR PURGE CONTROL (APC) SYSTEM
- Rocky Mountain Research, Inc.Nov 10, 1999
K992857 · LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070
- Stoeckert InstrumenteFeb 22, 1996
K955152 · STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER
- Jtl Medical Corp.May 20, 1993
K910599 · CARDIOPULMONARY BYPASS LEVEL SENSING MONITOR
- Sorin Biomedica, Fiat, USA, Inc.Feb 18, 1993
K924354 · STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR
- Terumo Medical Corp.Feb 21, 1992
K915337 · CAPIOX LEVEL ALARM
- Cobe Laboratories, Inc.May 22, 1990
K900910 · COBE AIR EMBOLI PROTECTION SYSTEM (AEPS)