CATHETER, PERITONEAL

Description of Event or Problem

THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT FROM A CONSUMER IN THE USA OF PERITONITIS IN A FEMALE PATIENT (BORN IN 1948) COINCIDENT WITH DIANEAL THERAPY. SUSPECT PRODUCT DETAILS: ON AN UNREPORTED DATE THE PATIENT BEGAN TREATMENT WITH DIANEAL THERAPY (DOSE, FREQUENCY AND LOT NUMBER NOT REPORTED), INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DIANEAL THERAPY IS ONGOING. EVENT DETAILS: DURING A CALL WITH BAXTER HOME CARE SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT BECAME TANGLED IN THE HOSPITAL BED AND WHEN THE PATIENT'S DAUGHTER TRIED HELPING HER SHE PULLED OUT THE CATHETER BY MISTAKE WHICH CAUSED PERITONITIS. ON AN UNKNOWN DATE, A PERITONEAL EFFLUENT CULTURE WAS PERFORMED HOWEVER THE RESULTS ARE UNKNOWN. THE HP WAS NOT HOSPITALIZED FOR THE PERITONITIS. TREATMENT WAS NOT REPORTED. THE PATIENT WAS RECOVERING FROM THE PERITONITIS. OUTCOME: PERITONITIS- RECOVERING. MEDICAL HISTORY: END STAGE RENAL DISEASE, HYPERTENSION, DIABETES, CARDIAC FAILURE, PNEUMONIA, CONGESTIVE HEART FAILURE- PATIENT HAD DEFIBRILLATOR PUT IN, RHEUMATOID ARTHRITIS, BREAST CANCER IN 2003 (PER PATIENT CANCER SPREADING TO SPINE). PATIENT INJURY REPORTED: YES, (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).