ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC
|
Back to Search Results |
|
Model Number IPN000254 |
Device Problem
Fluid/Blood Leak (1250)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/30/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Qn# (b)(4).
|
|
Event Description
|
It was reported that the balloon ruptured.The patient had been on their back and moving their arms around.The nurse noted blood filling up in the gas tubing.About 5 minutes after the blood was noted, the pump gave a "possible helium loss" alarm.It was noted that there had been no other issues with the balloon or pump prior to the blood in the gas tubing.It is possible that blood got into the pump.There is no blood in the condensation bottle.The pump will be sent to biomed to be inspected.As a result, the balloon was removed, and the patient was stable without the iab.There was no report of delay in therapy.There was no report of patient complication, serious injury, or death.
|
|
Event Description
|
It was reported, that the balloon ruptured.The patient had been on their back and moving their arms around.The nurse noted, blood filling up in the gas tubing.About 5 minutes after the blood was noted, the pump gave a "possible helium loss" alarm.It was noted, that there had been no other issues with the balloon or pump, prior to the blood in the gas tubing.It is possible, that blood got into the pump.There is no blood in the condensation bottle.The pump will be sent to biomed to be inspected.As a result, the balloon was removed.And the patient was stable without the iab.There was no report of delay in therapy.There was no report of patient complication, serious injury, or death.
|
|
Manufacturer Narrative
|
Qn# (b)(4).Teleflex received the device for investigation.The reported complaint of iab blood in helium pathway is confirmed.A puncture to the bladder, consistent with contact from the broken fiber, was found near the distal tip of the catheter, which allowed blood to enter the helium pathway.The root cause of the broken fiber is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed, the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.
|
|
Search Alerts/Recalls
|
|
|