BAXTER HEALTHCARE CORPORATION CLEARLINK CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR
|
Back to Search Results |
|
Catalog Number 2C8537 |
Device Problems
Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/26/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device was manufactured at one of the following facilities: baxter healthcare - cartago 600 mts.Oeste de entrada, principal ave.Las americas, parque industrial cartago 30106 costa rica baxter healthcare - dominican republic carretera sanchez km 18.5 parque industrial itabo, piisa haina, san cristobal 91000 dominican republic should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that there was a hole in the tubing below the check valve of a clearlink system continu-flo solution set which resulted in a leak.The issue was identified during priming with normal saline.There was no patient involvement.No additional information is available.
|
|
Manufacturer Narrative
|
Additional information: d4, g1 (additionally, remove reference to dominican republic from h10), h3, h4, h6 and h10.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection of the photograph was performed which identified a hole in the tubing below the check valve.The reported condition was verified.The cause of the hole could not be determined; however, a potential cause could be related to manufacturing.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
|
|
|