Manufacturer's investigation conclusion: a direct relationship between the device and the reported elevated lactate dehydrogenase (ldh), infection, renal dysfunction, and death could not be conclusively determined through this investigation.The relevant sections of the device history records for (b)(4) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The pump shipped on (b)(6) 2022.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) (rev.C) is currently available.Section 1 of this ifu, ¿introduction¿, lists infection, renal dysfunction, and death as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6, ¿patient care and management¿, provides information regarding the recommended anticoagulation therapy and inr range.This ifu and the heartmate 3 lvas patient handbook both outline care instructions for preventing infection.No further information was provided.The manufacturer is closing the file on this event.
|
It was reported that a recently implanted patient had increased white blood cell (wbc) and lactate dehydrogenase (ldh) levels on (b)(6) 2022; the patient became unstable and was taken to the operating room (or).The patient was noted to be chemically coding on the way to the operating room.After opening the patient's chest, the physician performed a cardiac massage and was able to stabilize the patient.The patient was placed on a venoarterial extracorporeal membrane oxygenator (va ecmo) and was transported back to the cardiovascular intensive care unit (cvicu).The patient was given intravenous vasopressors.Blood and sputum cultures taken revealed serratia marcescens and gram negative bacilli, indicating that the patient had developed sepsis.On (b)(6) 2022, the patient would not wake up and had no reflex responses during their neurological exam.The patient's continuous renal replacement therapy (crrt) was not successful at pulling adequate fluid and potassium out of the blood.The patient's family decided to remove care and the device was turned off; the patient passed away on (b)(6) 2022.The death was not considered to be device related and the device operated as intended.
|