Detector, Bubble, Cardiopulmonary Bypass
Cardiovascular · 21 CFR 870.4205
Recent MDR events
148 adverse event reports on file
- CAPIOXNov 7, 2024MalfunctionTerumo Corporation, Ashitaka9681834-2024-00193
- BUBBLE SENSOR DETECTORFeb 20, 2024MalfunctionLivanova Deutschland9611109-2024-00083
- BUBBLE SENSOR DETECTORFeb 16, 2024MalfunctionLivanova Deutschland9611109-2024-00080
- SORIN S3 BUBB DETECTORFeb 12, 2024MalfunctionLivanova Deutschland Gmbh9611109-2024-00075
- BUBBLE SENSOR DETECTORDec 29, 2023MalfunctionLivanova Deutschland9611109-2023-00665
- BUBBLE SENSOR DETECTORDec 21, 2023MalfunctionLivanova Deutschland9611109-2023-00648
- BUBBLE SENSOR DETECTOROct 11, 2023MalfunctionLivanova Deutschland9611109-2023-00517
- BUBBLE SENSOR DETECTOROct 4, 2023DeathLivanova Deutschland9611109-2023-00490
- S5 CONSOLE FOR 3 PUMPSep 5, 2023MalfunctionLivanova Deutschland Gmbh9611109-2023-00422
- BUBBLE SENSOR FOR 3/8 TUBINGJul 20, 2023MalfunctionLivanova Deutschland Gmbh9611109-2023-00340
Event type breakdown
Recalls
4 recall events for this product code
- Terumo Cardiovascular Systems CorporationTerminatedOct 8, 2010
Air bubble detection cable assembly, catalog numbers 78-8067-7375-6 and 149892, Terumo Cardiovascular System, Ann Arbor, MI
Malfunction of the air bubble detection cable assembly causes a false air alarm or a check sensor message during system set-up. In some instances, users were not able to reset the alarm to allow for further air bubble detection. .
Z-0024-2011 · View FDA record ↗ - Terumo Cardiovascular Systems CorpTerminatedJan 24, 2008
Terumo Ultrasonic air sensor, 3/8" by 3/32" (9.5 mm x 2.4 mm), Red, for use on Terumo perfusion systems 1, 8000 and 9000; Catalog No: 5773, Terumo Cardiovascula
False Alarms: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus preventing the device from being reset.
Z-0530-2008 · View FDA record ↗ - Terumo Cardiovascular Systems CorpTerminatedJan 24, 2008
Terumo ultrasonic air sensor, 1/4" by 1/16" (6.4 mm x 1.6 mm), Black, for use on Terumo perfusion systems 1, 8000 and 9000; Catalog No: 5785, Terumo Cardiovalvu
False Alarm: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus preventing the device from being reset.
Z-0531-2008 · View FDA record ↗ - Terumo Cardiovascular Systems CorpTerminatedJan 24, 2008
Terumo Ultrasonic air sensor, 1/4" by 3/32" (6.4 mm x 2.4 mm), Gold, for use on Terumo perfusion systems 1, 8000 and 9000; Catalog No: 5791, Terumo Cardiovascul
False Alarm: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus preventing the device from being reset.
Z-0532-2008 · View FDA record ↗
Registered firms
9 firms currently registered for this product code
Quest Medical, Inc.
ALLEN, TX, US
Terumo Cardiovascular Systems Corporation
ANN ARBOR, MI, US
Midwest Sterilization Corp.
JACKSON, MO, US
Ashitaka Factory Of Terumo Corp.
FUJINOMIYA Shizuoka, JP
Terumo Corp.
SHIBUYA-KU, TOKYO, JP
Livanova Deutschland Gmbh
MUNCHEN Bavaria, DE
Terumo Medical Canada, Inc.
Vaughan Ontario, CA
510(k) clearances
14 clearances for this product code
- Sorin Group Deutschland GmbHJan 18, 2011
K103469 · STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05
- Terumo Cardiovascular SystemsJun 8, 2009
K090698 · CAPIOX BUBBLE TRAP WITH X-COATING
- Luna Innovations, Inc.May 17, 2007
K071231 · EDAC QUANTIFIER
- Rocky Mountain Research, Inc.Oct 31, 1996
K961364 · AUTOMATIC TUBING CLAMP SYSTEM (ATC)
- Rocky Mountain Research, Inc.Oct 29, 1996
K961598 · ELS AUTOMATIC TUBING CLAMP SYSTEM
- 3M Health Care, SarnsMay 24, 1994
K940651 · SARNS ULTRASONIC AIR SENSOR
- 3M Health Care, SarnsFeb 4, 1994
K935977 · SARNS AIR DETECTION SYSTEM
- Sorin Biomedica, Fiat, USA, Inc.May 18, 1993
K925661 · STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE