Manufacturer's investigation conclusion: the report of a kinked outflow graft could not be confirmed as no computed tomography (ct) imaging was provided for review, and no product was returned for evaluation.The reported low flow alarms could not be confirmed as no log files were submitted for review.It was reported that the patient had ct chest angio + 3d reconstruction june 2020 showing mild folding in the distal aspect of the outflow graft without obstruction.The account reported low flow alarms since then.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 ii left ventricular assist system (lvas), (b)(6).No product is available for investigation.The relevant sections of the device history records for (b)(6) was reviewed and showed no deviations from manufacturing or quality assurance specifications.The lvas kit shipped on 17sep2018.Heartmate ii lvas instructions for use (ifu), section 5 entitled ¿surgical procedures¿ contains information regarding the preparation and attachment of the sealed outflow graft.This section instructs the user to verify that the graft is not twisted or kinked by checking the position of the black line on the graft above and below the bend relief and ensuring that the line is straight.This section warns that failure to connect the bend relief so that it is fully and evenly connected can allow kinking and abrasion of the graft, which may to serious adverse events such as low left ventricular assist device flow and/or bleeding.Section 4 entitled ¿system monitor¿ explains that pump flow is estimated based on pump power.Section 7 entitled ¿alarms and troubleshooting¿ outlines all system controller alarms, including the low flow hazard alarm, and provides information regarding how to respond to and troubleshoot the alarms.Section 6 entitled ¿patient care and management¿ provides information regarding anticoagulation therapy and the recommended inr range.Heartmate ii lvas patient handbook,section 5 entitled ¿alarms and troubleshooting¿ outlines all system controller alarms, including the low flow hazard alarm, and provides information regarding how to respond to and troubleshoot the alarms.No further information was provided.The manufacturer is closing the file on this event.
|