ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC
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Model Number IPN000254 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/17/2020 |
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 when the intra-aortic balloon (iab) was inserted the staff noticed that blood had backed into the helium driveline.As a result, the iab was removed and a new 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.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 revived risk.This will be monitored for any developing trends.
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Event Description
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It was reported that when the intra-aortic balloon (iab) was inserted the staff noticed that blood had backed into the helium driveline.As a result, the iab was removed and a new 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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