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 Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/18/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#: (b)(4).
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Event Description
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It was reported that immediately after insertion of the intra-aortic balloon (iab) and when the intra-aortic balloon pump (iabp) initiated pumping, blood was noted in tubing of the iab.The staff stated alarms were noted but were unsure of the exact alarms.As a result, a second iab was successfully inserted.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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(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.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.
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Event Description
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It was reported that immediately after insertion of the intra-aortic balloon (iab) and when the intra-aortic balloon pump (iabp) initiated pumping, blood was noted in tubing of the iab.The staff stated alarms were noted but were unsure of the exact alarms.As a result, a second iab was successfully inserted.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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