SIEMENS HEALTHCARE DIAGNOSTICS INC

RAPIDPOINT 405 · Cardiovascular

510(k): 0 Recall: 7 UDI: 0 MAUDE: 8 Class.: 63

Recalls (7)

RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, hematocrit

2018-07-16

Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas systems indicated. This may cause lower than expected values for carboxyhemoglobin (fCOHb) and methemoglobin (fMetHb). A negative interference with fCOHb has the potential to alter the medical assessment of the patient and may …

Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812, 1028322, 10313971 , 10310469

2016-09-02

Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge

Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN): 10282093, 10310464, 10314817, 1031 7193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784

2016-08-11

There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system

RAPIDPoint 405 Blood Gas Analyzer; Siemens Material Number: 10310464, 10322347, 10314817, 10317193, 10318999, 10320055, 10322347, 10328278, 10328302, 10336784. These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemogl

2014-12-30

Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable range of greater than 25 g/dl.

Siemens RAPIDPoint 400 system blood gas analyzer Product Usage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable

2012-09-17

RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample

Siemens RAPIDPoint 405 system blood gas analyzer Product PUsage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable

2012-09-17

RapidPoint 405 System Analyzers The RP405 is capable of testing all of the analytes listed below including Co-Oximetry. The Siemens 400 series system is intended for point of care and laboratory testing of blood gases, electrolytes and metabolites in arterial, venous and capillary whole blood samp

2009-10-30

Software: Reference sensor failure may result in inaccurate pH reuslts

MAUDE Adverse Events (8)

Malfunction

20140829

Malfunction

20140303

Malfunction

20140225

Malfunction

20140219

Other

20131005

Other

20130923

Other

20130914

Other

20130801

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