Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Death (1802)
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Event Date 07/19/2019 |
Event Type
Death
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Manufacturer Narrative
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The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).
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Event Description
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It was reported during use that the autofill failure occurs on cardiosave intra-aortic balloon pump (iabp).No obstructions noted to helium gas line.Several unsuccessful attempts made to reinstitute counter pulsation.Changed out console and successful counter pulsation reinstituted.The balloon counter pulsation therapy was interrupted for period of time on a critically ill patient.The patient subsequently expired the reported balloon had no reported malfunction.
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Event Description
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It was reported during use that the autofill failure occurs on cardiosave intra-aortic balloon pump (iabp).No obstructions noted to helium gas line.Several unsuccessful attempts made to reinstitute counter pulsation.Changed out console and successful counter pulsation reinstituted.The balloon counter pulsation therapy was interrupted for period of time on a critically ill patient.The patient subsequently expired.The reported balloon had no reported malfunction.
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Manufacturer Narrative
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The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Complaint record # (b)(4).
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Search Alerts/Recalls
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