Manufacturer's investigation conclusion: the reported thrombus in the centrimag circuit could not be confirmed through this evaluation as no images were submitted for review and the device was not returned for evaluation.The centrimag blood pump was not returned for evaluation.The outside united states (ous) centrimag blood pump instructions for use (ifu) warns the user to monitor the circuit carefully for any signs of occlusion.Additionally, this ifu states that the pump is intended to be used with systemic anticoagulation and anticoagulation levels should be determined by the physician based on risks and benefits to the patient.This document also instructs the user to always have a spare centrimag blood pump, back-up console, and equipment available for change out.Review of the device history record (dhr) for the centrimag blood pump revealed no deviations from manufacturing or quality assurance specifications.The ous centrimag blood pump ifu is currently available.The ifu contains the following additional warnings and precautions: ifu warning #9: possible side effects include but are not limited to: mechanical failure and embolic phenomena.Ifu warning #15: it is intended that systemic anticoagulation be utilized while this device is in use.Anticoagulation levels should be determined by the physician based on risks and benefits to the patient.Ifu warning #16: potential risk to the patient should be evaluated prior to changing a centrimag vad.Ifu warning #17: frequent patient and device monitoring is recommended.Ifu caution #2: this device should only be used by persons thoroughly trained in extracorporeal circulation procedures.Ifu caution #10: monitor carefully for any signs of occlusion throughout the circuit.Ifu caution #14: always have a spare centrimag blood pump, back-up console, and equipment available for change out.No further information was provided.The manufacturer is closing the file on this event.
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