The FDA today released information on a select voluntary recall from Getinge‘s (PINK:GETI B) Datascope and Maquet of its System CS100, CS100i and CS300 intra-aortic balloon pumps over issues with potential electrical test failures.
Datascope said they received a complaint in which the device failed to initiate therapy, resulting in a patient death. The complaint involved a CS300 IABP device which failed to pump due to electrical test failure code #58, a maintenance code and an autofill failure, according to the FDA notice.
The company said the electrical test failure code was caused by a solenoid valve requiring more power than the solenoid driver board could deliver to open the valve.
Datascope warned of additional associated hazards related to static condition in which the balloon will not inflate or deflate and could interrupt therapy.
To avoid the issue, the company suggested powering on the IABP prior to insertion to allow for the successful completion of of a self-test, which it says will take less than 60 seconds to perform, according to the FDA release.
Datascope recommended not leaving users unattended during IABP therapy due to the error, and said that if electrical test failure code #58 is observed, the operating physician should remove the IABP and contact Getinge.
The recall affects CS100i devices with part numbers 0998-UC-0446HXX and 0998-UC-0479HXX, CS100 devices with part numbers 0998-00-3013-XX and 0998-UC-3013-XX and CS300 devices with part numbers 0998-00-3023-XX and 0998-UC-3023-XX, according to the FDA release.
The company estimated that there are approximately 12,000 affected units sold globally, distributed between March 23, 2003 and Dec. 11, 2013. Units distributed after Dec. 11, 2013 are not affected by the field correction notice.
Datascope said that a service representative will replace defective solenoid driver boards, and that customers with affected units will be contacted by the rep to schedule the change.