Catalog Number IAB-05840-LWS |
Device Problems
Device Alarm System (1012); Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/13/2017 |
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 the pump alarmed "system leak".The tubing was assessed and no break/kink in the tubing was noted.The pump was turned on again and alarmed again for "system leak".The vascular surgeon at the field commented that there was bubbly "air" coming from the arteriotomy.As a result, the intra-aortic balloon (iab) was removed from the sheath and replaced with another iab.The tip of the fiber optic sensor (fos) line was observed to have punctured the balloon.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for investigation.The reported complaint of blood in helium pathway is confirmed based on visual inspection of the device.The cause of the complaint was unable to be determined due to the returned state of the device.The iab was returned with a broken central lumen piercing the bladder.Due to the damage, the device was unable to be fully functionally tested.The root cause of how the blood entered the helium pathway is undetermined.This issue will be monitored for any developing trends.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 risks.No further action required at this time.
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Event Description
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It was reported that the pump alarmed "system leak".The tubing was assessed and no break/kink in the tubing was noted.The pump was turned on again and alarmed again for "system leak".The vascular surgeon at the field commented that there was bubbly "air" coming from the arteriotomy.As a result, the intra-aortic balloon (iab) was removed from the sheath and replaced with another iab.The tip of the fiber optic sensor (fos) line was observed to have punctured the balloon.
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Search Alerts/Recalls
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