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CARDIOVASCULAR
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Volume 2, 1997, No 4 |
Abstract:
It has been known for some time that roller pumps can generate
interference with the electrocardiograph (ECG) signal. This
interference is believed to be caused by the same phenomenon that
produced a leak in the heat exchanger module of four of the new
Medtronic® Maxima Forté™ oxygenators. The new Maxima
Forté oxygenator is one of a new generation of oxygenators that
uses plastic fibers for the heat exchange material. The benefits
of the plastic fibers are improved in biocompatability and
performance over the traditional metal heat exchange materials.
The oxygenator underwent a rigorous series of laboratory and
animal testing during its development. The manufacturing process
also went through an extensive qualification and validation.
During the initial period of clinical use, there were reports of
four blood to water leaks. No patient complications were
associated with these leaks. After a thorough evaluation, the
cause of the leaks was found to be an electrostatic discharge
that occurred within the heat exchanger during priming of the
extracorporeal circuit. It was found that an electrostatic
potential between the blood path and the water path of the heat
exchanger is generated as the prime solution is recirculated.
Infrequently a discharge occurs through the wall of a single heat
exchange fiber. The magnitude of the potential generated was
found to be a function of the type of arterial pump and
pumpheader utilized. A roller pump with a polyvinyl chloride
(PVC) pumpheader was found to be the worst case situation.
Centrifugal blood pumps and silicone rubber pumpheaders were
found to generate no significant electrostatic potential. A
unique solution to this problem with roller pumps and a PVC
pumpheader, a charge equalization line (CEL), has been identified
and evaluated.
Keywords:
cardiac surgery, ECG interference, electrostatic discharge,
oxygenator, heat exchanger, plastic heat exchanger
Address for Correspondence:
Reference:
(CVE. 1997; 2 (4): 219-227)
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