CATHETER, PERITONEAL

Description of Event or Problem

THIS IS A REPORT FROM A CAREGIVER (CG) OF A HOME PATIENT (HP) THAT CONTACTED BAXTER TO REPORT THAT THE HP HAD PASSED AWAY. THE HP HAD EXPERIENCED ISSUES WITH DRAINING AND WAS HOSPITALIZED DUE TO THE PERITONEAL DIALYSIS CATHETER LEAKING FLUID INTO THE SUBCUTANEOUS TISSUE. THE CAUSE OF THE LEAK WAS UNKNOWN. THIS WAS RELATED TO THE CATHETER WHICH IS NOT A BAXTER PRODUCT. THE CAUSE OF DEATH LISTED ON THE HP'S DEATH CERTIFICATE WAS MYOCARDIAL INFARCTION. PRODUCT SURVEILLANCE CONTACTED THE NURSE TO OBTAIN CATHETER MANUFACTURER INFORMATION. THE NURSE STATED THAT SHE DID NOT KNOW THE MANUFACTURER OF THE CATHETER. NO FURTHER INFORMATION WAS PROVIDED. PATIENT INJURY REPORTED: YES (B)(4).THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).