Related manufacturer reference number: 1627487-2023-05606, 3006705815-2024-01381, 3006705815-2024-01382, 1627487-2024-07085.It was reported the patient was admitted to the hospital due to an infection on (b)(6) 2023.The patient was declared septic and intubated.The system was explanted on (b)(6) 2023 wherein it was found the infection had spread.The patient passed away on (b)(6) 2023.
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The system was explanted wherein it was found the infection had spread.The patient passed away.As a result, a device history record was performed to review and confirm the sterility of devices.Based on the documents reviewed, the source of the infection remains unknown.
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