Catalog Number 106015 |
Device Problem
Partial Blockage (1065)
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Patient Problem
Complaint, Ill-Defined (2331)
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Event Date 04/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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Unique identifier (udi) #: (device identifier) - (b)(4).(b)(4) approximate age of device ¿ 4 years and 8 months. additional information was requested, but was not provided.A supplemental report will be submitted when the manufacturer's investigation is completed.
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Event Description
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The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2014.It was reported that low flow alarms had occurred with possible inflow or outflow obstruction.The patient had been admitted to intensive care unit (icu) and placed on multiple infusions and vasopressors.On (b)(6) 2018, it was reported that the patient was too unstable to do any further investigation of the outflow and inflow.The patient¿s atrioventricular (av) did close on (b)(6) 2018.Additional information was requested, but was not provided.
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Manufacturer Narrative
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The evaluation of the submitted system controller log file confirmed the report of low flow alarms; however, a specific cause could not be conclusively determined through this evaluation.A review of the device history records revealed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.
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Event Description
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Additional information: it was reported that there were no further tests performed and the low flows improved on own without known reason.
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Search Alerts/Recalls
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