Catalog Number 5C5479 |
Device Problems
Disconnection (1171); Protective Measures Problem (3015)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/03/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that a low priority 30166 (max air exceeded) alarm occurred on an amia automated pd cycler set during peritoneal dialysis therapy.The patient was connected at the time of the alarm.This occurred during unknown phase of peritoneal dialysis therapy.During troubleshooting, it was reported that the tubing was disconnected inside the door of the amia automated pd cycler.Renal therapy services (rts) reviewed proper procedures with the patient.There was no patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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Additional information: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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