Catalog Number 5C5479 |
Device Problems
Material Puncture/Hole (1504); Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/19/2023 |
Event Type
malfunction
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Manufacturer Narrative
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D4: lot #: suspect lots h23f24034 and h23g10072.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 an unspecified quantity of amia automated pd cycler sets had holes and tiny tear in the patient line about one inch from the connection point and cap.This was observed during set up of the devices for peritoneal dialysis therapy.The patient started over with new supplies.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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D4: expiration date: suspect lot # h23f24034: 12/24/2025.D4: expiration date: suspect lot # h23g10072: 01/10/2026.H4: manufacture date: suspect lot # h23f24034: 09/20/2023.H4: manufacture date: suspect lot # h23g10072: 09/20/2023.H10: a batch review was conducted on the two suspect lot numbers and there were no deviations found related to this reported condition during the manufacture of these lots.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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