It was reported that after implant the patient had mediastinal bleeding, diffuse bleeding from all dissected raw surface and apical pump area, diffuse coagulopathy, and tamponade physiology with low flows.All cannulation and anastomotic sites were intact with no active surgical bleed.There were multiple clots in the mediastinum over the outflow graft and apical pump area, as well as pleural effusion in the right atrial gutter.The patient was given blood products.The bleeding resolved on (b)(6) 2022.
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Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the reported events could not be conclusively established through this evaluation.Additionally, the reported low flow alarms could not be confirmed through this evaluation as no log files were submitted for review.A specific cause for the alarms could not be conclusively determined through this evaluation.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6).No product is available for investigation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specification.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu), rev.C, and the heartmate 3 lvas patient handbook, rev.D, are currently available.Section 1 of the ifu, ¿introduction¿, lists bleeding and pericardial fluid collection as adverse events that may be associated with the use of the heartmate 3 lvas.This section also addresses all pump parameters, including pump flow.Section 4, ¿system monitor¿, describes the pump flow display and the hazard alarms.The ifu states that per design, when the estimated flow value is calculated at less than 2.5 lpm, a low flow status is posted to the log file.If the flow remains below 2.5 lpm for 10 seconds, a low flow hazard alarm is triggered.This section also explains that changes in patient condition can result in low flow.Section 6 of the ifu, ¿patient care and management¿, provides information regarding the recommended anticoagulation regimen and international normalized ratio (inr) values as well as suggested anticoagulation modifications in the event that there is a risk of bleeding.Section 7 of the ifu, "alarms and troubleshooting", and section 5 of the patient handbook, "alarms and troubleshooting", address all system alarm conditions as well as the appropriate actions associated with each condition.Furthermore, section 8 of the patient handbook, ¿handling emergencies¿, also provides examples of emergencies and the proper actions to take in the event an emergency occurs.No further information was provided.The manufacturer is closing the file on this event.
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