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 12/29/2020 |
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 in use, the staff experienced "possible helium loss" alarm and noticed blood in the tubing.As a result, the iab was removed and therapy was discontinued.The patient was stable without the intra-aortic balloon pump (iabp).There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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Qn# (b)(4).No part was returned to teleflex chelmsford for investigation.The reported complaint for iab "blood in the tubing " is not able to be confirmed.If the product is returned at a later date, a full investigation of the sample will be completed.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 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 in use, the staff experienced "possible helium loss" alarm and noticed blood in the tubing.As a result, the iab was removed and therapy was discontinued.The patient was stable without the intra-aortic balloon pump (iabp).There was no report of patient complications, serious injury or death.
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