(b)(6).An alarm indicative of a potential malfunction of the disposable cassette was reported.The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.However, a loose connection was reported between the supply line of the homechoice cassette and supply bag, which is known to cause this alarm.The cause of the loose connection could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
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It was reported that a homechoice device experienced a system error 2240 (air in line/set) alarm.The patient was connected at the time of the alarm.This occurred during dwell phase of peritoneal dialysis therapy.During troubleshooting, the connection of the supply bag to tubing was loose that led to this alarm; air was found in the supply line however, no leak was observed.Renal therapy services (rts) advised the patient to close all clamps and assisted with clearing the alarm.The patient would drain manually.Proper procedures per the user manual were reviewed with the patient.There was no patient injury or medical intervention associated with this event.No additional information is available.
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