SynCardia TAH-t Instructions for Use
SynCardia Systems, Inc.
Page 9
6.4
SynCardia TAH-t Reliability:
Reliability testing was conducted to determine with reasonable assurance how
long a device would perform as intended, without failure.
Three separate sets of
in vitro
reliability testing were conducted. In one test,
four TAH-t units were run for a period of 180 days. During this time there
were no failures or abnormalities observed.
In a second
in vitro
reliability trial, four TAH-t units were tested in a “run to
failure” study design and are ongoing. After 35 months of testing, there were
no failures or abnormalities observed.
A third test was initiated using three TAH-t units which had expired their 3
year sterilization expiration date. This provided information about the effects
of long-term storage on the fatigue resistance properties of the TAH-t. After
24 months of testing, there were no failures or abnormalities observed.
In conclusion, a total of eleven units have been run for various lengths of time
over the last six years with no device-related failures. The cumulative number
of days used for calculation was 6715 and there have been no failures or signs
of appreciable wear observed. When the 11 units are used to calculate
reliability with a 90% confidence, the reliability at 30, 60 and 365 days is as
reported in the table below.
Table 2
Reliability Test Results with 90% Confidence
Reliability in number of days run
# days run
MTBF*
30
60
365
6715 2916 0.99
0.98
0.88
