Catalog Number 5C5479 |
Device Problem
Material Puncture/Hole (1504)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/05/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that there was a pinhole in the tubing of an amia automated pd cycler set.This was observed during set up 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.
|
|
Manufacturer Narrative
|
Should additional relevant information become available, a supplemental report will be submitted.
|
|
Manufacturer Narrative
|
Additional information was added to h6 and h10.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.
|
|
Search Alerts/Recalls
|