It was reported that the patient had pseudomonas bacteremia and driveline exit site infection.Patient was given cefepime for 6-10 weeks.Symptoms of nausea/vomiting, fatigue, pain, and fever.Event date was estimated and will not be provided.
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Related mfr numbers: 2916596-2022-12239, 2916596-2022-12240, 2916596-2022-12243, 2916596-2022-12244 and 2916596-2022-12246.Manufacturer's investigation conclusion: the pump remained in use until the patient expired (mfr# 2916596-2022-12207).A correlation between the device and the report of infection could not be conclusively determined.Infection is listed in the instructions for use as a potential adverse event that may be associated with the use of heartmate 3 left ventricular assist system.Infection has been previously investigated and will continue to be monitored through quality data reviews, which are conducted on production and post product signals to evaluate if products are conforming to product requirements.No further information was provided.The manufacturer is closing the file on this event.
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