Model Number IPN000254 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/06/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that the intra-aortic balloon (iab) ruptured during use on the patient.The staff noted that blood have backed into the helium tubing.The iab was removed in the late evening.As a result, the user elected to manage the patient without the iab and no other iab was inserted.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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Qn# (b)(4).Teleflex received the device for investigation.The reported complaint of iab blood in helium pathway is confirmed.The intra-aortic balloon catheter (iabc) bladder had a full thickness abrasion, which caused the blood to enter the helium pathway.The appearance of the abraded area is consistent with repeated contact with calcified plaque on the aortic wall.The root cause of the bladder leak is related to patient condition.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.
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Event Description
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It was reported that the intra-aortic balloon (iab) ruptured during use on the patient.The staff noted that blood have backed into the helium tubing.The iab was removed in the late evening.As a result, the user elected to manage the patient without the iab and no other iab was inserted.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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