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 08/12/2021 |
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 the balloon was placed after the patient had become severely hypotensive and on a high dose of pressers.The patient did not improve on the balloon pump, so a few hours later they placed an impella with the intra-aortic balloon (iab) left in place.Several hours later the balloon pump began to alarm for helium loss, and blood was noted in the gas tubing.As a result, the iab was removed without difficulty.The iab was discarded as the patient is covid positive.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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(b)(4).The product was not returned for investigation.The reported complaint of iab blood in helium pathway is not able to be confirmed.The root cause of the complaint 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 the balloon was placed after the patient had become severely hypotensive and on a high dose of pressers.The patient did not improve on the balloon pump, so a few hours later they placed an impella with the intra-aortic balloon (iab) left in place.Several hours later the balloon pump began to alarm for helium loss, and blood was noted in the gas tubing.As a result, the iab was removed without difficulty.The iab was discarded as the patient is covid positive.There was no report of patient complications, serious injury or death.
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