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SORIN GROUP USA INC

S5 · Cardiovascular

510(k): 0 Recall: 10 UDI: 0 MAUDE: 10 Class.: 63

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Recalls (10)

S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.

2012-09-19

Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determi

S5 Double Roller Pump 85, Item Number: 10-85-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.

2012-09-19

Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determin

S5 Mast Roller Pump 85, Item Number: 10-88-60 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.

2012-09-19

Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determin

S5 Mast Roller Pump 150, Item Number: 10-88-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.

2012-09-19

Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determin

Sorin C5 Perfusion System, Item number 58-00-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.

2012-09-19

Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determin

Stockert, S5 Roller Pump 150, Part No.: 10-80-00, Sorin Group Deutschland Gmbh, Lindberghstrasse 25, Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004. Used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.

2010-11-12

Touch screen may become unresponsive, inhibiting user input.

Stockert, S5 Double Roller Pump 85, Part No.: 10-85-00, Sorin Group Deutschland Gmbh, Lindberghstrasse 25, Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004. Used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.

2010-11-12

Touch screen may become unresponsive, inhibiting user input.

S5 Display and Control Module, Part No.: 28-95-10, Sorin Group Deutschland Gmbh, Lindberghstrasse 25, Munchen, Germany. Used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.

2010-11-12

Touch screen may become unresponsive, inhibiting user input.

S5 Mast Roller Pump System 85, Part No.: 28-95-80, Sorin Group Deutschland Gmbh, Lindberghstrasse 25, Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004. Used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.

2010-11-12

Touch screen may become unresponsive, inhibiting user input.

S5 Control Panel for 2 Mast Roller Pumps 85, Part No.: 28-95-85, Sorin Group Deutschland Gmbh, Lindberghstrasse 25, Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004. Used to perform, control and monitor extracorporeal blood circulation during an operation for up to six h

2010-11-12

Touch screen may become unresponsive, inhibiting user input.

MAUDE Adverse Events (10)

Injury

20150923

Malfunction

20150116

Death

20141115

Other

20140704

Other

20140602

Other

20131024

Other

20130807

Malfunction

20100825

Malfunction

20091201

Malfunction

20080421

FDA Classification (63)

Cpr Aid Feedback Device (No Software)

Cardiovascular

Dilator, Vessel, For Percutaneous Catheterization

Cardiovascular

Predictive Indicator For Long-Term Cardiovascular Outcomes

Cardiovascular

Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon

Cardiovascular

Pulse Oximeter For Over-The-Counter Use

Cardiovascular

Introducer, Catheter

Cardiovascular

Catheter, Oximeter, Fiber Optic, Reprocessed

Cardiovascular

Transducer, Blood-Pressure, Extravascular

Cardiovascular

Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

Cardiovascular

Low Patient Acuity Monitoring System

Cardiovascular

Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement

Cardiovascular

Outpatient Cardiac Telemetry

Cardiovascular

Apical Closure Device

Cardiovascular

Filter, Intravascular, Cardiovascular

Cardiovascular

Cardiovascular Surgical Instruments Tray

Cardiovascular

Digital Angiography Tray

Cardiovascular

Pulse-Generator, Pacemaker, External

Cardiovascular

Ultrasonic Body Composition Analyzer

Cardiovascular

Coronary Mechanical Thrombectomy With Aspiration

Cardiovascular

Catheters, Transluminal Coronary Angioplasty, Percutaneous

Cardiovascular

Bag, Polymeric Mesh, Pacemaker

Cardiovascular

Transducer, Heart Sound

Cardiovascular

Central Venous Catheter Tray

Cardiovascular

Septostomy Catheter, Reprocessed

Cardiovascular

Oximeter, Tissue Saturation

Cardiovascular

Catheter, Intravascular, Diagnostic

Cardiovascular

Ballistocardiograph

Cardiovascular

Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures

Cardiovascular

Monitor, St Segment

Cardiovascular

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Cardiovascular

Software Device System For Estimation Of Cardiac Pressures

Cardiovascular

Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass

Cardiovascular

Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate

Cardiovascular

Dc-Defibrillator, Low-Energy, (Including Paddles)

Cardiovascular

Peripheral Mechanical Thrombectomy With Aspiration

Cardiovascular

Vectorcardiograph

Cardiovascular

Reprocessed Blood Pressure Cuff

Cardiovascular

Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures

Cardiovascular

Optical Coherence Tomography, Intravascular Catheter

Cardiovascular

Holder, Heart-Valve, Prosthesis

Cardiovascular

Magnet, Test, Pacemaker

Cardiovascular

Marker, Cardiopulmonary Bypass (Vein Marker)

Cardiovascular

Catheter, Thrombus Retriever

Cardiovascular

Percutaneous Catheter, Ultrasound

Cardiovascular

Syringe, Balloon Inflation

Cardiovascular

Catheter, Intravascular Occluding, Temporary

Cardiovascular

Cannula, Catheter

Cardiovascular

Detector And Alarm, Arrhythmia

Cardiovascular

Loss Of Pulse Notification Software

Cardiovascular

Winged Intravenous Catheterization Kit

Cardiovascular

Device, Vascular, For Promoting Embolization

Cardiovascular

Cardiovascular Delivery Catheter System Positioning And Stabilization Device

Cardiovascular

Over-The-Counter Automated External Defibrillator

Cardiovascular

Suction Control, Intracardiac, Cardiopulmonary Bypass

Cardiovascular

Injector, Contrast Medium, Automatic, Reprocessed

Cardiovascular

Clip, Vascular

Cardiovascular

Oximeter, Infrared, Sporting, Aviation

Cardiovascular

Oximeter, Ear

Cardiovascular

Electrocardiograph Software For Over-The-Counter Use

Cardiovascular

Filter, Prebypass, Cardiopulmonary Bypass

Cardiovascular

Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation

Cardiovascular

Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass

Cardiovascular

Computer, Diagnostic, Programmable

Cardiovascular