Catalog Number IAB-S840C |
Device Problem
Fluid/Blood Leak (1250)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/17/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that 5 minutes after a therapy was initiated, blood was found in the helium pathway.As a result, the iab was removed and a 2nd iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".
|
|
Manufacturer Narrative
|
Qn#(b)(4).N/a other remarks: n/a.Corrected data: n/a.
|
|
Event Description
|
It was reported that 5 minutes after a therapy was initiated, blood was found in the helium pathway.As a result, the iab was removed and a 2nd iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine.".
|
|
Manufacturer Narrative
|
Qn# (b)(4).The reported complaint for "blood in gas line" is not able to be confirmed.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 is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.If the product is returned at a later date, a full investigation of the sample will be completed.Other remarks: n/a.Corrected data: n/a.
|
|
Search Alerts/Recalls
|