Description of Event or Problem · 1
PT WAS BORN ON 2/9/96 AND FOUND TO HAVE HYPOPLASTIC LEFT HEART SYNDROME. SHE WAS TRANSFERRED TO THIS HOSPITAL ON 2/10/96 FOR SURGICAL REPAIR OF THIS CONDITION.THIS PT WAS TAKEN TO SURGERY ON 2/14/96 FOR A MODIFIED STAGE I NORWOOD PROCEDURE UNDER CARDIOPULMONARY BYPASS AND HYPOTHERMIA. THE 9MM PULMONIC VALVE USED IN THIS PROCEDURE WAS OBTAINED FROM A TISSUE CENTER. AT THE TIME OF SURGERY, THIS GRAFT WAS THAWED ACCORDING TO THE PROVIDER'S INSTRUCTIONS AND FOUND TO BE DISINTEGRATING AND DISSECTING. AS THE PT WAS ALREADY ON BYPASS, THERE WAS NO TIME TO OBTAIN ANOTHER GRAFT SO THE SURGEONS USED AS MUCH OF THE GRAFT AS THEY FEASIBLE COULD. THE PROCEDURE WAS COMPLETED BUT WHEN THE CHILD WAS WEANED FROM BYPASS SHE BECAME HEMODYNAMICALLY UNSTABLE AND BRADYCARDIC. CPR WAS INITIATED BUT THE PT EXPIRED AT 6:10 P.M. ON 2/14/96.THE TISSUE CENTER HAS BEEN NOTIFIED OF THE CONDITION OF THE GRAFT AND THE DEATH OF THE PT.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. 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. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.