MAUDE Adverse Event Report: UNKNOWN PD CATHETER,; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Device Problem Microbial Contamination of Device (2303)

Patient Problems Atrial Fibrillation (1729); Peritonitis (2252); Multiple Organ Failure (3261)

Event Date 02/06/2021

Event Type  Death  

Event Description

It was reported that a patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized due to peritonitis and expired on (b)(6) 2021.Due to these events, it was reported the patient transitioned to hemodialysis (hd) for rrt through a temporary intrajugular (ij) hd catheter (not a fresenius product).During follow-up, the patient's peritoneal dialysis registered nurse (pdrn) verified the patient was hospitalized on (b)(6) 2021 for abdominal pain and cloudy peritoneal effluent fluid.A peritoneal effluent fluid culture and cell count (elevated wbc's, value unavailable) was obtained, and the patient was diagnosed with peritonitis.The pdrn reported the patient was started on intraperitoneal (ip) antibiotics (drugs, doses, frequency, duration not provided), however the peritoneal effluent fluid culture returned positive for pseudomonas aeruginosa on (b)(6) 2021 and the patient's pd catheter (not a fresenius product) was removed.The porn stated causality was never identified, as the patient never returned to the outpatient home dialysis clinic.However, the pdrn stated the patient's liberty select cycler was performing as expected and did not malfunction prior to the patient's hospitalization.On (b)(6) 2021, the patient received a temporary hemodialysis (hd) catheter (not a fresenius product) in order to undergo hd for rrt.The patient's condition reportedly started to decompensate (specifics/dates not provided), and radiological studies discovered the patient had developed an ileus.Although the details are largely unknown, the pdrn reported the patient's health further deteriorated (i.E., uncontrolled atrial fibrillation, multisystem organ failure), and on (b)(6) 2021 the patient entered into hospice care.The intention was to have the patient continue to undergo hd therapy, however the patient expired on (b)(6) 2021 before hd had begun.The pdrn stated there was no report of any fresenius device(s) and/or product(s) malfunction and/or deficiency.Additional information (e.G., discharge summary, death certificate, treatment records, esrd death notification, hospital records) was requested, however the documents were unavailable.The catheters used by the patient are not fresenius devices.The manufacturer of the catheters, and further product information, are unknown.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PD CATHETER,
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17533533
• MDR Text Key: 321042541
• Report Number: MW5140437
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1