Catalog Number 5C5479 |
Device Problems
Disconnection (1171); Air/Gas in Device (4062)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Event Description
|
It was reported that a patient line tip protector of three (3) amia automated pd cycler sets fell off after priming which would result in air in the lines.It was unknown if the patient was connected at the time of the event.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 devices were discarded; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|