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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Injury (2348)
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Event Date 09/10/2020 |
Event Type
Injury
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Manufacturer Narrative
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A company representative has advised that the customer has not alleged a malfunction of the iabp, and the pump model and serial number have not been provided.If additional information is provided, a supplemental report will be submitted.
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Event Description
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It was reported that while in use, blood was barely seen in the gas line of a datascope manufactured intra-aortic balloon pump (iabp).The iabp type is unknown.The iabp was then placed in stand-by mode 1.5 hours prior to the intra-aortic balloon catheter (iabc) removal because the patient was heparinized.When the cardiologist attempted removal of the iabc, it was found to be entrapped, so it was necessary to remove it surgically.There was no reported malfunction of the iabp by the customer.The intra-aortic balloon catheter has been submitted under a separate manufacturer¿s report, reference report 2248146-2020-00517.
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Event Description
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It was reported that while in use, blood was barely seen in the gas line of a datascope manufactured intra-aortic balloon pump (iabp).The iabp type is unknown.The iabp was then placed in stand-by mode 1.5 hours prior to the intra-aortic balloon catheter (iabc) removal because the patient was heparinized.When the cardiologist attempted removal of the iabc, it was found to be entrapped, so it was necessary to remove it surgically.There was no reported malfunction of the iabp by the customer.The intra-aortic balloon catheter has been submitted under a separate manufacturer¿s report, reference report 2248146-2020-00517.
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Search Alerts/Recalls
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