BAXTER HEALTHCARE CORPORATION MINICAP TRANSFER SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
|
Back to Search Results |
|
Catalog Number 5C4482 |
Device Problem
Failure to Disconnect (2541)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/08/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that there was a connection issue between a peritoneal dialysis (pd) transfer set and the patient line of the homechoice cassette.This occurred during use of the device for pd therapy.The connection issue was further described as, ¿could not disconnect the patient line from the dark blue body of the transfer set¿.To resolve this issue, the transfer set was replaced.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
|
|
Manufacturer Narrative
|
H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.The photograph was visually inspected, and it was noted that the transfer set was connected to the white connector of the cassette with the tubing cut, which suggested that there was a connection issue.The reported condition was verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|
|
|