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Catalog Number IAB-S730C |
Device Problems
Device Alarm System (1012); Fluid/Blood Leak (1250); Material Rupture (1546)
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Patient Problems
Vessel Or Plaque, Device Embedded In (1204); Death (1802); Low Blood Pressure/ Hypotension (1914)
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Event Date 08/17/2018 |
Event Type
Death
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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 intra-aortic balloon (iab) was inserted into the patient and later that night the staff had frequent "possible helium loss" alarms.The perfusionist was called to troubleshoot.There were no signs of blood in the tubing, or a kink and all the connections were tight.The alarm stopped.During the morning, the staff again experience "possible helium loss" alarm.At this time it was noticed there was a slight amount of blood in the gas drive tubing.As a result, the cardiologist was notified and the iab was removed with difficulty.The patient was sent to the operating room (or) for removal.A second iab was inserted on the right femoral artery.The vascular surgeon had to cut the iab to get the iab out.A clot was noted in the balloon.There was a report of patient's death after returning to the intensive care unit.
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Manufacturer Narrative
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(b)(4).Teleflex did not receive the device for investigation.The reported complaint of "blood in helium pathway" is not able to be confirmed.The product was not returned for investigation.The root cause of the complaint is undetermined.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed manufacturing specifications prior to release.The reported complaint will be monitored for any developing trends.No further action required at this time.
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Event Description
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It was reported that the intra-aortic balloon (iab) was inserted into the patient and later that night the staff had frequent "possible helium loss" alarms.The perfusionist was called to troubleshoot.There were no signs of blood in the tubing, or a kink and all the connections were tight.The alarm stopped.During the morning, the staff again experience "possible helium loss" alarm.At this time it was noticed there was a slight amount of blood in the gas drive tubing.As a result, the cardiologist was notified and the iab was removed with difficulty.The patient was sent to the operating room (or) for removal.A second iab was inserted on the right femoral artery.The vascular surgeon had to cut the iab to get the iab out.A clot was noted in the balloon.There was a report of patient's death after returning to the intensive care unit.
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Search Alerts/Recalls
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