ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 257 CM (101") APPX 18.5 ML, 20 DROP BLOOD SET W/200 MICRON FILTER, BACK CHECK VA; STOPCOCK, I.V. SET
|
Back to Search Results |
|
Catalog Number 011-C6032 |
Device Problems
Disconnection (1171); Fluid/Blood Leak (1250)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/01/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device is expected to be returned for evaluation, however, it is not yet received.
|
|
Event Description
|
The event involved a 257 cm (101") appx 18.5 ml, 20 drop blood set w/200 micron filter, back check valve, 2 clave¿ clear, spin luer.The customer stated that the iv tubing disconnected from the filter chamber in the middle of patient use.The solution used was a compound sodium lactate.The set was replaced, rimed another set and continued surgery.There was no specific damage noted on the set like crack or breakage.There was patient involvement, no patient harm, no delay in therapy and no one was harmed as a result of the reported event.This report is one of two.
|
|
Event Description
|
The incident occurred on an unspecified date.
|
|
Manufacturer Narrative
|
Two used samples #011-c6032 were returned for evaluation, one of them was connected one used unknown extension tubing.As received it was confirmed a tube separation from the drip chamber.The tube was observed through uv light and was confirmed insufficient presence of solvent, no additional damage or anomalies were confirmed.The outside of diameter of tube was measured and confirmed to be within specification.Complaint of separation can be confirmed.The probable cause is due to insufficient solvent applied during manual process assembly at manufacturing.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.
|
|
Search Alerts/Recalls
|
|
|