BAXTER HEALTHCARE CORPORATION MINICAP TRANSFER SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
|
Back to Search Results |
|
Catalog Number 5C4482 |
Device Problem
Difficult to Open or Close (2921)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/20/2024 |
Event Type
malfunction
|
Event Description
|
It was reported that the twist clamp of a minicap extended life pd transfer set could not be closed.This was discovered prior to use of the device for peritoneal dialysis (pd) therapy.There was no patient involvement.No additional information is available.
|
|
Manufacturer Narrative
|
E1: initial reporter facility name: should additional relevant information become available, a supplemental report will be submitted.
|
|
Manufacturer Narrative
|
H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing including leak, clear passage, and clamp function testing were performed with no issues noted.Torque engagement testing was performed, the engage and disengage force to open and close the twist sleeve was acceptable and met specification.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|
|
|