Description of Event or Problem · 1
DURING CARDIOPULMONARY RESUSCITATION OF THE PATIENT, RIGHT SUBCLAVIAN CENTRAL LINE WAS BEING PLACED. WIRE WAS THREADED WITHOUT DIFFICULTY, DILATOR WAS PASSED, AND CATHETER WAS THREADED. WHEN GUIDE WIRE WAS BEING WITHDRAWN IT DID NOT MOVE PROPERLY. THE WIRE APPEARED BROKEN. THE CATHETER AND GUIDE WIRE WERE REMOVED WITH EASE. A NEW CATHETER PACKAGE WAS OPENED AND THE CATHETER WAS INSERTED WITHOUT DIFFICULTY. EXAMINATION BY BIOMEDICAL ENGINEERING FOUND AN APPROXIMATE 30 DEGREE BEND IN THE INNER WIRE PORTION OF THE SPRING GUIDE WIRE. THE BEND WAS LOCATED APPROXIMATELY 40 PERCENT UPSTREAM FROM THE DISTAL END OF THE CATHETER. THE PATIENT EXPIRED, BUT WAS IN FULL ARREST UPON ARRIVALDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: OTHER. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.