Model Number 106524US |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Fever (1858); Pain (1994); Post Operative Wound Infection (2446)
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Event Date 06/26/2020 |
Event Type
Injury
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Manufacturer Narrative
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No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
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Event Description
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It was reported that the patient developed an infection at the thoracotomy site on (b)(6) 2020.The patient was treated with antibiotics and discharged (b)(6) 2020.No additional information was reported.
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Manufacturer Narrative
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Manufacturer's investigation conclusion: the pump remains in use supporting the patient.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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Event Description
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The patient had been experiencing symptoms of pain, erythema, low grade fevers, and leukocytosis related to the thoracotomy infection.Infectious diseases recommended a 10 day course of cephalexin.
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Search Alerts/Recalls
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