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 12/12/2020 |
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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The device was returned for investigation.Upon review of the sample, it was found that the intra-aortic balloon (iab) had blood that entered the helium pathway.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 fos would not zero is confirmed.The fos fiber was broken and therefore the light path could not be established between the sensor and the pump.Additionally, unrelated to the reported complaint, dried blood was noted within the helium pathway upon return.A puncture to the bladder, consistent with contact from the broken fiber, was found near the distal end of the bladder membrane 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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The device was returned for investigation.Upon review of the sample, it was found that the intra-aortic balloon (iab) had blood that entered the helium pathway.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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