Description of Event or Problem · 1
A NURSE REPORTED THAT A PT BEGAN TAKING COUMADIN 2.5 MG FIVE DAYS A WEEK AND 5 MG TWO DAYS A WEEK APPROXIMATELY ONE YEAR AGO FATRAIL FIBRILLATION AND CVA (CEREBROVASCULAR ACCIDENT). ON THE MORNING OF 30-NOV-94 HER PT (PROTHROMBIN TIME) WAS 15.0 SECONDS USING A COUMAATRAK PROTIME TEST SYSTEM MONITOR IN THE PHYSICIAN'S OFFICE. THE TEST WAS REPEATED USING A SECOND SITE, WITH A RESULT OF 18.6 SECONDS. THE PT COMPLAINED OF NOSEBLEEDS OFF AND ON. THE DOSAGE WAS REDUCED TO 2.5 MG QD. ON THE NIGHT OF 30-NOV-94, SHE WAS ADMITTED TO THE HOSPITAL VIA THE ER (EMERGENCY ROOM) FOR ABDOMINAL PAIN UNRELATED TOBLEEDINGPT WAS 50 SECONDS IN THE HOSPITAL LABORATORY. THE NURSE PRESUMED THAT COUMADIN WAS DISCONTINUED. ON THE MORNING OF DEC-1-94, HER PT WAS STILL 50 SECONDS. A MEMBER OF THE HOSPITAL LABORATORY STAFF INDICATED THAT THIS PT'S PROTHROMBIN TIME HAD BEEN IN THE 40-50 SECOND RANGE AND THAT, AS OF DEC-2-94, HER PT WAS BACK DOWN TO ABOUT 20 SECONDS. THE COUMATRAK MONITOR HAD BEEN OPERATED BY THE PHYSICIAN'S OFFICE STAFF. PROPER TECHNIQUES AAND USE OF CONTROLS WERE CONFIRMED WITH TWO OF THE SFATT NURSES. ONE NURSE INDICATED THAT THE COUMATRAK MONITOR IS GENERALLY UNPLUGGED WHEN USED. SHE NOTED THAT WHEN UNPLUGGED FOR LESS THAN 30 MINUTES, THE MONITOR INDICATES THAT THE BATTERY IS LOW. NO OTHER PROBLEMS WITH THE MONITOR WERRE STATED. SHE NOTED THAT THERE WERE NO PROBLEMS WITH ANY OTHER PT. THE OTHER NURSE STATED THAT THE PHYSICIAN HAS LOST CONFIDENCE IN THE COUMATRAK MONITOR BECAUSE OF THE LACK OF CORRELATION BETWEEN THE MONITOR AND THE HOSPITAL LABORATORY PT RESULTS FOR THIS PT. A REPLACEMENT MONITOR WAS PROVIDED AND WAS CONFIRMED TO BE PERFORMING PROPERLY. THE MONITOR IN QUESTON WILL BE RETURNED TO THE MAUNUFACTURER FOR EVALUATION.