Model Number 1103 |
Device Problems
Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Post Operative Wound Infection (2446)
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Event Date 08/28/2017 |
Event Type
Injury
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Manufacturer Narrative
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This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation and destination therapy in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.The device remains implanted in the patient and is thus not available for return to the manufacturer.With a review of the available information there is no evidence to indicate any device malfunctions or performance issues that would impact the reported events.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to this event.This event was assessed and is being reported as part of a retrospective review of log file data.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the patient was admitted with pump pocket infection.The ventricular assist device (vad) remains implanted.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: (b)(4) was not returned for evaluation.This complaint is associated with a clinical adverse event, no device malfunction was reported against (b)(4); therefore, the purpose of this investigation is solely to evaluate the device conformance to internal release requirements and/or to identify anomalies potentially introduced during use that may have prevented the pump from performing as intended.Review of the sterility certificate confirmed that the associated device met all requirements for release.Log file analysis revealed that the pump's power consumption was within the normal operating range for the past 14 days until (b)(6) 2017.Based on the investigation conducted, there is no evidence to suggest that a device malfunction caused or contributed to the reported event.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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