One disposable was received for evaluation.Visual inspection found the disposable to be in used condition, and the bond between the coil tube and entrance of the filter was observed to be occluded.To conduct functional testing, the disposable was primed and set to be ran with a cadd legacy pump.He fluid did not pass through the unit and the alarm high pressure? was activated.The reported failure mode, pump alarm, is confirmed.The root cause was determined to be the occlusion in the bond between the coil tube and filter entrance due to an excess of solvent.This was caused by failure to properly follow manufacturing procedure.No lot number was provided; therefore, a device history record (dhr) review could not be conducted.
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