BAXTER HEALTHCARE CORPORATION CLEARLINK SYSTEM SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR
|
Back to Search Results |
|
Catalog Number 2R8401 |
Device Problem
Fluid/Blood Leak (1250)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/05/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
E1: initial reporter address: (b)(6).G1: device manufacturer address 1: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that three (3) clearlink system, non-dehp solution sets leaked from connection between the drip chamber and tubing.This occurred during priming.There was no patient involvement.No additional information is available.
|
|
Manufacturer Narrative
|
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
|
|
|