On (b)(6) 2019, 6 hours and 31 minutes into therapy, account called with an alternating white c red thermometer/blue thermometer alarm.Ekos catheter was placed to treat a bilateral pulmonary embolism (pe).Ultrasound was paused.After troubleshooting, the staff reconnected and started ultrasound and yellow light flashing.The connector interface cable (cic) was on top of the blankets, dressing was clean and intact, and iv tubing/roller clamps/stopcocks were all open.Patient was stable and on a ventilator.During follow-up, the customer stated when trying to pull out ultrasound wire it was stuck and stretched.On (b)(6), two catheters were returned without the marker bands.Upon follow-up, the customer informed that "the patient did well" and there was "nothing left in the patient" because they would have seen the marker band on fluoroscopy.One intelligent drug delivery catheter (iddc) was difficult to remove and extended and stretched during removal.The account stated that they did not think that hemostasis valve was used.
|