Sorin—Perfusion Systems: Pump Speed Control Knob May Fail

ECRI Institute’s complete weekly summary of medical device hazard and recall information is available in ECRI Institute’s Health Devices Alerts(HDA). For more information about HDA, contact us at clientservices@ecri.org.

In a December 4, 2013, Field Safety Notice letter submitted by an ECRI Institute member hospital, Sorin states that it has received reports of pump speed control knob failures on the below-listed systems, resulting in no response when turned. The speed indicator LEDs did not light up, and an alarm message, "Shaft angle encoder fault," was displayed on the system panel. All failures occurred during setup or shortly after being placed into clinical use. The firm adds that it has received no reports of patient injuries related to the problem. The pump speed control knob is attached to the shaft of an encoder used to adjust the speed. The problem is related to a change of the optical encoder module, which has introduced a smaller gap between the code wheel and the detector. The process of placing the shaft encoder into the control panel may deform the shaft encoder body, allowing the code wheel to contact the detector, potentially damaging the encoder. The firm states that it has improved the assembly process and has subsequently received no reports of shaft encoder issues. The manufacturer has not confirmed the...