Catalog Number IAB-06830-U |
Device Problem
Fluid/Blood Leak (1250)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/16/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Qn# (b)(4).Other remarks: n/a.Corrected data: n/a.
|
|
Event Description
|
Reported as "blood noted in helium drive line".The report states, "[the user] called the hotline to an iabc rupture.A small amount of blood was noted in the helium drive line approximately 3 hours post insertion.Iab appears to be entrapped in the femoral artery near the insertion site.The patient is currently stable and [the user] will update me if there are any additional complications or issues with removal".No patient harm or injury.The patient status is reported as "fine".Additional information from the customer states they cannot confirm if the patient required a surgical cutdown or not.
|
|
Manufacturer Narrative
|
(b)(4).The reported complaint for "blood noted in helium drive line" was not able to be confirmed as the product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint was undetermined.No further action required at this time.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
|
|
Event Description
|
Reported as "blood noted in helium drive line".The report states, "[the user] called the hotline to an iabc rupture.A small amount of blood was noted in the helium drive line approximately 3 hours post insertion.Iab appears to be entrapped in the femoral artery near the insertion site.The patient is currently stable and [the user] will update me if there are any additional complications or issues with removal".No patient harm or injury.The patient status is reported as "fine".Additional information from the customer states they cannot confirm if the patient required a surgical cutdown or not.
|
|
Search Alerts/Recalls
|