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CGMP Deviations
The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.
Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cause MPU not to turn on, unprompted shut down, or turning off/restarting, may cause system controller to indicate Yellow Wrench or No External Power alarms. If MPU losses power, System Controller can support the pump up to 15 minutes, and if not switched to rechargeable batteries, pump may lose power.
Chemical contamination: Presence of benzene
cGMP deviations
Due to manufacturing issues there is a potential for the catheter sheath to detach.
The potential for cracks forming in the breathing circuit hose.