Model Number IPN000255 |
Device Problems
Fluid/Blood Leak (1250); Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/11/2020 |
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 patient arrived from the or and the staff experienced helium loss 2 alarms.The staff noted blood in the tubing and the intra-aortic balloon (iab) was removed.There was no difficulty in removing the iab and the patient was stabled after removal and discharged from the hospital.There was no report of patient complications, serious injury or death.
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Event Description
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It was reported that when the patient arrived from the or and the staff experienced helium loss 2 alarms.The staff noted blood in the tubing and the intra-aortic balloon (iab) was removed.There was no difficulty in removing the iab and the patient was stabled after removal and discharged from the hospital.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.During the investigation, a puncture to the bladder, consistent with contact from a sharp object, was found on the bladder membrane which allowed blood to enter the helium pathway.No other leaks were detected during functional testing.The root cause of the bladder leak is undetermined.A potential cause is customer handling.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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Search Alerts/Recalls
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