ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 71" EXT SET W/MICROCLAVE® CLEAR, 3 GANG 1O2® MANIFOLD W/BASEPLATE (BLUE, GREEN,; STOPCOCK, I.V. SET
|
Back to Search Results |
|
Model Number MC5008 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/08/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device is expected to be returned for evaluation.It has not been received.
|
|
Event Description
|
The event involved a 71" ext set w/microclave® clear, 3 gang 1o2® manifold w/baseplate (blue, green, yellow), check valve, 3 remv ext w/3 remv microclave® clear, 1 remv smallbore ext w/clave® clear, clamp where it was reported that the tubing has debris on it but unsure if any debris are within the tubing.The debris looked cloudy white sticky residue outside of the tubing.The reporter added that the device was considered contaminated and had to open another tubing.The incident happened in the operating room.The particulate was noted first in the original hospira container.The product is stored in room temperature with all other sterile anesthesia supplies based on ornac standards.There was no report of patient involvement or patient harm.
|
|
Manufacturer Narrative
|
Received one used extension set (mc5008) with dry fluid residuals on the outside of the tubing that was attached to the yellow port on the manifold.The dry residual was also on the outside of the female luer bonded to the tubing and on the outside of the clear microclave.Subsequent leak testing did not reveal any leakage at any bond or connection location.This suggests that the fluid residue came from an external source.The probable cause of the fluid residuals on the outside of the tubing, female luer, and microclave cannot be determined but was unlikely to have originated from the mc5008 extension set fluid path due to damage or a manufacturing defect.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.
|
|
Search Alerts/Recalls
|
|
|