PD CATHETER

Description of Event or Problem

A PERITONEAL DIALYSIS (PD) PATIENT CONTACT REPORTED TO (B)(6) CUSTOMER SUPPORT THAT THE PATIENT WAS HOSPITALIZED AND DOESN'T NEED DELIVERIES. THE PATIENT HAS HAD COMPLICATIONS WITH THE PD CATHETER (NOT A (B)(6) PRODUCT) DUE TO PD TREATMENT. FOLLOW-UP WITH THE PATIENT¿S PD REGISTERED NURSE (PDRN) REVEALED THE PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2025 WITH COMPLAINTS OF SEVERE ABDOMINAL PAIN. A PERITONEAL EFFLUENT FLUID CULTURE AND CELL COUNT (RESULTS NEGATIVE) WERE COLLECTED, AND THE PATIENT WAS FORMALLY ADMITTED. RADIOLOGICAL STUDIES DETERMINED THAT THE PATIENT¿S PD CATHETER MIGRATED OUT OF POSITION, AND THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR A REVISION. HOWEVER, ONCE THE SURGEON ENTERED THE PATIENT¿S ABDOMEN THERE WERE MULTIPLE ADHESIONS FOUND, AND A ¿HOLE¿ IN THE PATIENT¿S COLON WAS DISCOVERED. GIVEN THESE FINDINGS, THE PATIENT¿S PD CATHETER WAS REMOVED, AND THE PATIENT WAS SENT TO RECOVERY. ONCE, THE PATIENT WAS AWAKE A FAMILY MEETING WAS HELD TO DISCUSS THE PATIENT¿S CONDITION. THE PATIENT NEEDED EMERGENCY SURGERY TO CLOSE THE HOLE IN HER COLON, HOWEVER HER LIST OF COMORBIDITIES AND THE LEVEL OF ANTICOAGULANT IN HER BLOOD MADE SURGERY EXTREMELY RISKY. THE PATIENT AND FAMILY DISCUSSED THE PATIENT¿S OPTIONS AND DECIDED TO MOVE FORWARD WITH THE SURGERY. THE PATIENT SURVIVED THE SURGERY, HOWEVER ON THE MORNING OF (B)(6) 2025 THE PATIENT EXPIRED DUE TO COMPLICATIONS FROM THE SURGERY. PER THE PDRN, THE SERIOUS ADVERSE EVENTS WERE NOT CAUSED BY ANY (B)(6) PRODUCT(S) AND/OR DEVICE(S) DEFICIENCY OR MALFUNCTION. BASED ON THE AVAILABLE INFORMATION, THE LIBERTY SELECT CYCLER CAN BE DISASSOCIATED FROM HAVING A CAUSAL OR CONTRIBUTORY ROLE IN THE SERIOUS ADVERSE EVENTS EXPERIENCED BY THE PATIENT. THERE IS NO ALLEGATION OR OBJECTIVE EVIDENCE INDICATING A SERIOUS INJURY, PATIENT DEATH, OR OTHER SERIOUS ADVERSE EVENT(S) RELATED TO A (B)(6) DEVICE(S) AND/OR PRODUCT(S) OCCURRED WARRANTING FURTHER INVESTIGATION. FURTHERMORE, THERE WAS NO REPORT A (B)(6) DEVICE(S) AND/OR PRODUCT(S) FAILED TO MEET THE USERS¿ EXPECTATIONS AND/OR THE MANUFACTURERS¿ SPECIFICATIONS. THE REPORTED EVENT IS RELATED TO THE USE OF A PD CATHETER (NON-(B)(6) PRODUCT). THE MANUFACTURER OF THE CATHETER, AND FURTHER PRODUCT INFORMATION, IS UNKNOWN. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".