ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" EXT SET W/0.2 MICRON FILTER, CLAVE¿ CLEAR, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET
|
Back to Search Results |
|
Catalog Number MC9013 |
Device Problem
Fluid/Blood Leak (1250)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/28/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.Possible lot number: 13870091, manufacturing date: 1/1/2024, expiration date: 1/1/2029.
|
|
Event Description
|
The event involved a 14" ext set w/0.2 micron filter, clave¿ clear, clamp, rotating luer where it was reported during infusion of paclitaxel a leak was noticed.The customer stated that the dose was a 24-hour infusion of paclitaxel, with concentration around 0.8mg/ml.It was reported that according to the patient the leak occurred later on during the infusion.The dose was started on (b)(6) 2023 at 22:31, and on (b)(4) 2023 about 3pm, the patient was sitting on the bed and noticed liquid on right lower side of their gown.It was found that liquid was bubbling from the inline filter ¿ filter was replaced.There was patient involvement and unknown human harm reported.
|
|
Search Alerts/Recalls
|
|
|