Description of Event or Problem · 1
33 YEAR OLD PATIENT WITH A HISTORY OF CIRRHOSIS, END STAGE LIVER DISEASE, HEPATITIS C, HEPATIC ENCEPHALOPATHY UNDERWENT A LIVER TRANSPLANTATION ON 1/11/92. HIS POST-OPERATIVE COURSE WAS UNSTABLE, MARKED BY COAGULOPATHY, SEPSIS INTERMITTENT HEMODYNAMIC INSTABILITY, PULMONARY EDEMA, PNEUMONIA AND BILATERIAL PLEURAL EFFUSIONS. AT 11:30 A.M. ON 2/29/92 THE PATIENT UNDERWENT A RIGHT THRACENTESIS (USING THE 16 GUAGE 3 INCH THORACENTESIS NEEDLE) TO CHECK THE RIGHT PLEURAL EFFUSION FOR INFECTION. DURING THE PROCEDURE THE PATIENT DEVELOPED HEMOPTYSIS, TENSION PNEUMOTHORAX AND CARDIAC ARREST. BILATERAL CHEST TUBES WERE INSERTED AND A SECOND ARREST WITH WAS TREATED WITH CPR, CARDIAC MEDICATIONS, AND DEFIBRILLATION WITH SUCCESS. BRONCHOSCOPY REVEALED A LARGE CLOT AT THE CARINA. DUE TO THE PROLONGED ARREST, RESUSCITATION EFFORTS WERE DISCONTINUED, AND PATIENT EXPIRED AT 3:00 P.M. ON 2/29/92DEVICE NOT 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 NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.