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Model Number 0998-00-3013-XX |
Device Problems
Flushing Problem (1252); Aspiration Issue (2883)
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Patient Problem
Death (1802)
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Event Date 03/22/2017 |
Event Type
Death
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Event Description
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The customer reported that on (b)(6) 2017 during procedure, difficulty of flush inner lumen after located iab in a patient vessel.Customer replaced syringe to continue therapy, however it was still unable to vacuum blood, and eventually removed catheter.After catheter was removed, the surgeon attempted to inflate it, but iab did not inflate.The surgeon is suspecting that blood back run after removed guide wire.The patient died on (b)(6) 2017.Iabp therapy discontinued.The customer has attributed the patient death to the intra-aortic balloon malfunction and not to a malfunction of the intra-aortic balloon pump.Furthermore, an additional report will be submitted with information regarding the intra-aortic balloon ((b)(4)).
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Manufacturer Narrative
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(b)(4).The production device history record (dhr) for this iabp unit was reviewed and no non-conformances related to the reported event were noted.The company representative reported that there was no alleged malfunction of the cs100 unit involved in this event, as the unit worked normally and was never taken out of clinical service by the customer.
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Event Description
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The customer reported that on (b)(6) 2017 during procedure, difficulty of flush inner lumen after located iab in a patient vessel.Customer replaced syringe to continue therapy, however it was still unable to vacuum blood, and eventually removed catheter.After catheter was removed, the surgeon attempted to inflate it, but iab did not inflate.The surgeon is suspecting that blood back run after removed guide wire.The patient died on (b)(6) 2017.Iabp therapy discontinued.The customer has attributed the patient death to the intra-aortic balloon malfunction and not to a malfunction of the intra-aortic balloon pump.Furthermore, an additional report will be submitted with information regarding the intra-aortic balloon (under trackwise #135415/ca-cpl-2017-00813).
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Search Alerts/Recalls
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