Description of Event or Problem · 0
SITUATION: POTENTIAL STAPLER MALFUNCTION RESULTING IN UNEXPECTED SURGICAL COMPLICATION. BACKGROUND: ELDERLY PATIENT PRESENTED TO SPOR FOR A DONOR NEPHRECTOMY, FOR LIVING KIDNEY DONATION (LEFT) ON [REDACTED DATE]. DURING SURGERY, WHEN THE SURGEON ATTEMPTED TO CUT AND STAPLE THE RENAL ARTERY, BLEEDING WAS NOTED. VASCULAR SURGERY WAS CALLED EMERGENTLY TO ASSIST, AND THE PATIENT WAS IMMEDIATELY TRANSITIONED FROM LAPAROSCOPIC TO OPEN SURGERY TO BETTER ASSESS THE ORIGIN OF BLEEDING. IT WAS FOUND THAT THE STAPLE THAT WAS FIRED ACROSS THE RENAL ARTERY PEDICLE FAILED, AND AN AORTIC INJURY WAS NOTED. THIS WAS SUTURED AND REPAIRED WITH GOOD HEMOSTASIS. THE PATIENT HAD AN ESTIMATED BLOOD LOSS OF OVER 2L AND REQUIRED RESUSCITATION WITH 4.5 L OF CRYSTALLOID, A MASSIVE TRANSFUSION PROTOCOL INCLUDING 3 UNITS OF RED CELLS AND 2 UNITS OF PLASMA ALONG WITH 460CC FROM THE CELL SAVER. THE BASELINE HEMATOCRIT WAS 41 AND DROPPED TO 26 INTRAOPERATIVELY. THE KIDNEY WAS SUCCESSFULLY REMOVED, AND THE PATIENT WAS CLOSED AND EXTUBATED PRIOR TO TRANSFER TO THE ICU FOR HEMODYNAMIC MANAGEMENT AND RECOVERY. THE PATIENT IS CURRENTLY STABLE, REQUIRING NO ADDITIONAL BLOOD PRODUCTS AND IS NOT REQUIRING ANY HEMODYNAMIC SUPPORT. THE SURGEON DISCUSSED THE EVENT WITH THE PATIENT AND WILL FOLLOW UP WITH THE CLEAR RESOURCES. THE PRODUCTS (STAPLER AND STAPLES) INVOLVED IN THE EVENT HAVE BEEN SEQUESTERED. SECOND VICTIM SUPPORT WILL BE OFFERED AND ONGOING. ASSESSMENT: PERIOPERATIVE SERVICES IS REQUESTING A PEER REVIEW TO HELP DETERMINE IF THIS WAS USER ERROR VS PATIENT ANATOMY/PRODUCT MALFUNCTION. INITIAL INTERVIEWS SHOW NO APPARENT DEVIATIONS IN GENERALLY ACCEPTED PRACTICE STANDARDS. RECOMMENDATION: CLASSIFICATION OF THIS EVENT WILL BE PENDING PEER REVIEW. A BRIEF REVIEW SHOWS NO READILY IDENTIFIABLE SYSTEM OPPORTUNITIES. WE ARE REQUESTING A CROSS CHECK FROM OUR REGULATORY PARTNERS RELATED TO THE POSSIBLE REPORTING CATEGORY FOR THE CT DEPARTMENT OF HEALTH, NQF 2B. PATIENT DEATH OR SERIOUS INJURY ASSOCIATED WITH THE USE OR FUNCTION OF A DEVICE IN PATIENT CARE, IN WHICH THE DEVICE IS USED OR FUNCTIONS OTHER THAN AS INTENDED. ¿THIS IS A PRIVILEGED AND CONFIDENTIAL PATIENT SAFETY WORK PRODUCT AS PROVIDED BY THE FEDERAL PATIENT SAFETY QUALITY IMPROVEMENT ACT OF 2005. DO NOT DISCLOSE WITHOUT AUTHORIZATION.¿ MANUFACTURER RESPONSE FOR STAPLER, (BRAND NOT PROVIDED) (PER SITE REPORTER).