CARDIOVASCULAR
ENGINEERING
Journal for Extracorporeal Circulation, Assist Devices,Transplantation and Artificial Organs
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CARDIOVASCULAR
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Volume 1, 1996, No 1 |
Abstract:
With nonocclusive centrifugal pumps, retrograde flow can occur
whenever the pump malfunctions, the pump stops, or when the
pressure produced by the pump is less than the pressure required
for forward flow. Retrograde flow can produce a hemodynamic
siphon that can exsanguinate the patient and can draw air into
the arterial line at the cannulation site. Food and Drug
Administration (FDA) records were obtained to determine the
incidence of centrifugal pump failures. FDA records show 93
medical device reports were received for centrifugal pumps over a
23-month period. There were 68 malfunctions, 22 electrical
burning smells, and three speed surges. Approximately 350,000
open-heart procedures on centrifugal pumps were completed during
this period, yielding a failure rate of 1 in 3,763 cases. FDA
files contain five death reports and three serious injury reports
for centrifugal pumps. A follow-up survey was distributed to
2,424 Society of Thoracic Surgeons’ (STS) members to obtain
additional information. Three hundred and seventy-one surgeons
(15%) returned the follow-up survey. Overall, 285 respondents use
centrifugal pumps for ventricular assistance and cardiopulmonary
bypass. Sixty surgeons reported 108 malfunctions, including 46
complete failures. Twenty-one electrical burning smells and 26
speed surges were reported. When asked did the failure cause
patient injury, three said yes, 61 said no, and five were unsure.
When asked did the failure contribute to patient death, two said
yes, 64 said no, and three were unsure. We conclude that
centrifugal pumps are safe. However, malfunctions and human
errors can lead to air entering the arterial line. There are
inexpensive valves to protect against these risks.
Keywords:
centrifugal pumps, air embolism, pump failure, cardiopulmonary
bypass
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