Description of Event or Problem · 1
IN THE RECOVERY ROOM AT 1152, FOLLOWING A BILATERAL BREAST REDUCTION, THE NURSE NOTED BLEEDING FROM THE RIGHT BREAST SITE. THE SURGEON WAS CALLED AND ADVISED THE NURSE TO HOLD PRESSURE FOR 10 MINUTES, WRAP WITH AN ACE BANDAGE, AND THEN REASSESS. AT 1215, THE AREA WAS REASSESSED: BLEEDING WAS MINIMAL, APPROXIMATELY 30 CC, AND THE AREA HAD NOT SOAKED THE ACE WRAP. AT 1255, THE PATIENT WAS NOTED TO BE DIAPHORETIC AND DIZZY WITH A BLOOD PRESSURE OF 80/20. THE RIGHT BREAST WAS NOTICEABLY LARGER AND FIRM TO TOUCH. EPHEDRA WAS ADMINISTERED BY ANESTHESIA. THE PATIENT WAS RETURNED TO THE OR FOR EVACUATION OF A RIGHT BREAST HEMATOMA. THE PATIENT WAS DISCHARGED THE FOLLOWING MORNING WITH NO FURTHER PROBLEM.IT WASN'T UNTIL THERE WERE TWO MORE CASES SIMILAR TO THIS ONE THAT USE OF THE COLORADO TIP WAS IDENTIFIED, THROUGH A ROOT CAUSE ANALYSIS, AS THE POSSIBLE COMMON CAUSE; THE SURGEON HAD ONLY RECENTLY BEGUN TO USE THIS PARTICULAR DEVICE FOR THIS PROCEDURE. (BOTH OF THE OTHER CASES ARE ALSO BEING REPORTED). THE SAME SURGEON WAS INVOLVED IN ALL 3 EVENTS. IT IS UNKNOWN IF THE SURGEON WAS USING THE DEVICE DIFERENT FROM WHAT IS RECOMMENDED. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER, THEY WERE UNAWARE OF THE POSSIBLE LINK BETWEEN THE 3 CASES FOR ALMOST 3 MONTHS AFTER THE LAST ONE WAS DONE.