UNKNOWN

Description of Event or Problem

PATIENT ADMITTED FOR REMOVAL OF CAPD CATHETER. PATIENT HAS HAD PERITONITIS X 2; HAS BEEN ONMULTIPLE ANTIBIOTICS FOR TREATMENT OF SUCH. MISSED ONE DOSE OF ANTIBIOTICS AND HAD AN ACUTE EPISODE OF PERITONITIS. HAD ALSO PREVIOUSLY HAD A CUFF INFECTION WITH SUBSEQUENT DEBREDEMENT OF CUFFDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: THERE WAS NO DEVICE FAILURE, OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: USE OF ALL SIMILAR DEVICES STOPPED TEMPORARILY. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.