An alarm indicative of a potential malfunction of the disposable set was reported.The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.However, a leak was reported from the heater bag line of the amia cassette, which is known to cause this alarm.The cause of the leak 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 low priority 30166 (max air exceeded) alarm occurred on an amia automated pd system during peritoneal dialysis therapy.This alarm occurred during fill four while the patient was connected.During troubleshooting, it was discovered that there was leak from the heater bag line of an amia cassette set.No damage noted on the heater bag.To resolve the issue, the patient started therapy over with new supplies.Renal therapy services (rts) reviewed proper procedures per the user manual with the patient.Continuous ambulatory peritoneal dialysis was discussed.There was no patient injury or medical intervention associated with this event.No additional information is available.
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