Datascope Corp. is performing a voluntary global field correction of certain intra-aortic balloon pumps (IABP). The company received a complaint that an electrical test failure code #58 cause a device to fail to initiate therapy, which has been associated with a patient death. According to a news release on the Maquet Getinge Group website (Datascope is part of Maquet Getinge), this type of electrical test failure code occurs when a solenoid valve requires more power than the solenoid driver board can deliver to open the valve. The incident involved a CS300 IABP.
The 12,000 affected devices were distributed in the United States and more than 100 countries, and were distributed between March 23, 2003 and December 11, 2013. The field correction applies to any System 98 or System 98XP IABP that was converted to a CS100i or CS300 IABP.
“Patients receiving IABP therapy are in critical condition and sudden interruption of therapy could result in unsafe, hemodynamic instability. Maquet/Getinge indicates that the risk-benefit of using an affected CS100i, CS100 or CS300 IABP should be assessed by the medical team for each patient when no alternative IABP or alternative therapy is available,” according to the news release. On its website Maquet/Getinge has provided several actions that users should follow if they must operate the affected devices.
The company states that a Datascope service representative will be replacing the defective solenoid driver boards of the affected devices.