Description of Event or Problem · 1
ON JUNE 18, 1994, AFTER A SWAN WAS DISCONNECTED LEAVING THE SHEATH IN PLACE, THE ONE WAY VALVE FAILED TO SEAL. IV FLUID INFUSING THROUGH THE SIDE PORT LEAKED OUT OF THE VALVE THROUGH WHICH THE SWAN WAS DISCONTINUED. ATTEMPTS TO CAP THE VALVE WERE UNSUCCESSFUL. DOPAMINE DOSAGE WAS IMPACTED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. 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: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.