An alarm indicative of a potential malfunction of the disposable cassette was reported.The device was discarded and the lot number is unknown; therefore, a device analysis could not be completed.However, a disconnection was reported between the final line of the homechoice cassette and the final bag, which is known to cause this alarm.The cause of the disconnection 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 home patient (hp) was connected at the time of the alarm.This occurred during unknown process step of peritoneal dialysis therapy.During troubleshooting, it was reported that the bag disconnected from the final line that was used as a supply line.During follow up, it was confirmed that the hp set up therapy correctly and the connections were properly tightened before the start of therapy.No loose connection or damages were noted between the supply line and supply bag.Renal therapy services (rts) explained the alarm and advised the hp to inform their nurse for further instruction on completing therapy.Proper procedures per the user manual were reviewed with the hp.There was no patient injury or medical intervention associated with this event.No additional information is available.
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