CATHETER, PERITONEAL
Received Aug 12, 2023
Report MW5136346 · MDR key 17529419
Device
Generic name
Catheter, Peritoneal
Manufacturer
UnknownProduct problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
Unknown
- Peritonitis
- Peritonitis
Narrative
Description of Event or Problem
THIS IS A SPONTANEOUS REPORT FROM A CONSUMER WITH SUPPLEMENTAL INFORMATION FROM A NURSE IN THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL THERAPY FOR PERITONEAL DIALYSIS. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2013, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE CAUSES OF PERITONITIS WERE URINARY TRACT PROBLEMS AND THE CATHETER SPRUNG A LEAK (ONSET DATES NOT REPORTED). ON AN UNREPORTED DATE, A PERITONEAL EFFLUENT CULTURE WAS PERFORMED AND THE RESULT WAS UNKNOWN. TREATMENT WAS NOT REPORTED. ON (B)(6) 2013, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT. PATIENT INJURY REPORTED: YES. MEDICAL INTERVENTION REQUIRED: YES, (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).