Manufacturer's investigation conclusion: a specific cause for the reported fibrin formation could not be conclusively determined.A direct correlation between the reported events and the pedimag blood pump could not be conclusively established through this evaluation.Multiple requests for additional information regarding this event were submitted to the account; however, no response has been received at this time.The pedimag blood pump was not returned for evaluation.The pedimag blood pump instructions for use (ifu) lists embolic phenomena as possible side effects that may be associated with the use of the pedimag blood pump (ifu warning #3).The ifu cautions that placing a tubing clamp near a tubing connection point can damage the connector, resulting in thrombus formation at the area of damage (in the section titled ¿recommended pumphead priming procedure¿).The subsection titled indications for use explains that the pedimag blood pump is indicated for use with the centrimag console and motor to pump blood through a complete extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours) for surgical procedures such as a mitral valve reoperation.It is also indicated for use in extracorporeal support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.G.Valvuloplasty, surgery of the vena cava or aorta, liver transplants etc.).The ifu contains the following additional warnings and cautions: ifu warning #1: the pedimag blood pump has not been qualified through in vitro, in vivo, or clinical studies for long term use (i.E., longer than six hours) as a bridge to transplant, for pending recovery of the natural heart or for extracorporeal membrane oxygenation.Ifu warning #9: 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 #23: use of this pump for periods longer than durations appropriate to cardiopulmonary bypass procedures may result in pump failure, reduced pumping capacity, excessive blood trauma, degradation of blood contact materials with possibility of particles passing through the blood circuit to the patient, leaks, and increased potential for gaseous emboli.Ifu caution #9: monitor carefully for any signs of occlusion throughout the circuit.Ifu caution #15: always have a spare pedimag blood pump, back-up console, motor, and accessories available for change out.The lot number or other identifying information of the product was not reported and was not able to be determined during the investigation.No further information was provided.The manufacturer is closing the file on this event.
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