Investigation summary: the report of an irregularly shaped white washer can be confirmed.During implant, the or team noted an irregular shape to the white washer of the outflow elbow.A photo of the washer was submitted.The team did not feel comfortable using this pump, so they obtained another implant kit and successfully implanted the patient.The pump was returned with the driveline intact and the outflow elbow properly attached.Examination of the distal side of the outflow elbow revealed the reported irregularly shaped white washer.A specific cause for the warping of the washer cannot be conclusively determined.The heartmate ii lvas ifu provides detailed instructions for pump preparation prior to implant and states to examine the outflow elbow of the pump to verify the presence of a white washer.If the white washer is missing or damaged, do not use the pump.Obtain another device before continuing.Furthermore, the ifu warns that "during the implant process, a complete backup system (implant kit and external components) must be available on-site and in close proximity for use in an emergency.No further information was provided.The manufacturer is closing the file for the event.
|