ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8" (20CM) APPX 0.48ML, SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING LU; STOPCOCK, I.V. SET
|
Back to Search Results |
|
Catalog Number Z0792 |
Device Problem
No Flow (2991)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/01/2023 |
Event Type
malfunction
|
Event Description
|
The customer returned 4 used devices for investigation.Fluid flow occlusions were confirmed in all four of the returned used z0792 extension set assemblies, however, no leakage was observed.This captures 3 of 4 devices.
|
|
Manufacturer Narrative
|
Received one used.List #z0792, 8" (20cm) appx 0.48ml, smallbore ext set w/0.2 micron filter, clamp, rotating luer; lot #9285958.Fluid flow occlusion was confirmed in the returned used z0792 extension set assembly; however, no leakage was observed.The probable cause of the occluded flow is a filter clog.The dfu states: a filter that clogs during infusion should be replaced.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.
|
|
Search Alerts/Recalls
|
|
|