During a monthly maude review, it was discovered that a user facility had reported the following incident: during the arthroscopic diagnostic part of an acl reconstruction, the ar-6480 pump malfunctioned.The pump never displayed a change of pressure (was always between 30-35) but continued to run at a high speed for a very short time.All the fluid from two 3-liter bags went into the patient.The pump was stopped.The patient's leg became swollen and could not be flexed.Surgeon made the decision to abort the acl procedure.The incision was closed and dressing was applied.The patient was taken to pacu where her leg was still swollen but softer to touch.Patient was observed overnight and was then discharged home in stable condition.Per user facility policy, the device and tubing were sent for inspection.No initial user facility medwatch reporter contact information or facility information was available on the maude report.No follow up will be possible.
|