BAXTER HEALTHCARE CORPORATION MINICAP TRANSFER SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
|
Back to Search Results |
|
Catalog Number 5C4482 |
Device Problems
Fluid/Blood Leak (1250); Difficult to Open or Close (2921)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/12/2024 |
Event Type
malfunction
|
Event Description
|
It was reported that the twist clamp of the minicap extended life pd transfer set ¿cannot be closed¿ which resulted in a leak.This was observed prior to use 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
|
E1: initial reporter facility name:.H10: the device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Manufacturer Narrative
|
The actual device was returned for evaluation.A visual inspection noted that the twist clamp will not align with the notch on the main body.Functional leak and clear passage tests were performed and no issues were noted.A clamp function test was performed and it was noted that the twist clamp detent would not fully lock in position.The reported condition of leak through the twist clamp was not verified; however, the reported condition of twist clamp could not be closed was verified.The device did not meet product specifications.The cause of the condition was determined to be a manufacturing related issue.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|
|
|