Catalog Number 5C5479 |
Device Problem
Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that there was a hole in the heater bag line (towards the top where it laid over the bag) of the amia automated pd cycler set.This was observed during setup of the device for peritoneal dialysis therapy.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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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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Manufacturer Narrative
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H10: 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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