D
Patient 1
7/12/92 PT. PRESENT AS OUT PATIENT FOR ROUTINE FLUSING OF PORT-A-CATH. UNIT WILL NOT FLUSH OR ASPIRATE. 7/13/92 PT. SEEN BY SURGEON. TUBING HAS DISCONNECTED FROM PORTA CATH AND IS LOCATED IN PULMONARY ARTERY. 7/14/92 TUBING REMOVED IN CATH LAB FORSYTH MEMORIAL HOSPITAL. 7/16/92 RESVOIR REMOVED DAVIE COUNTY HOSPITAL. PT. SAID DHE WAS TOLD TUBING HAD BEEN OFF ABOUT 5 WEEKS FROM THE FIBROSIS AROUND IT. UNIT HAS BEEN IN SINCE 1/9/90.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY 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: NONE OR UNKNOWN. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.