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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypoglycemia (1912); Peritonitis (2252); Fungal Infection (2419)

Event Date 11/15/2020

Event Type  Death  

Event Description

A peritoneal dialysis registered nurse (porn) reported to fresenius that a patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis (ccpd) for renal replacement therapy (rrn expired on (b)(6) 2020).Additionally, the porn reported the cause of death was unknown, however the patient was not connected to the liberty select cycler or liberty cycler set when the event(s) occurred.During follow up, the porn reported the patient's primary cause of death was hypoglycemia, secondary to fungal peritonitis.The porn reiterated the patient had been battling hypoglycemia for quite some time, and causality had not yet been determined prior to their death.However, the porn reported ccpd therapy and the use of any fresenius products has been ruled out.The patient was found collapsed next to their bed in the late afternoon.Emergency medical services (ems) were contacted, however upon their arrival it was determined the patient passed several hours prior and resuscitative measures were not undertaken.The patient was not undergoing ccpd therapy at the time of their death, and no alarms were noted during a review of the patient's last ccpd treatment.The porn confirmed the patient was diagnosed with fungal peritonitis on (b)(6) 2020.They were then informed their pd catheter (not a fresenius product) would require removal and they would need to transfer to incenter hemodialysis (hd) while their abdomen healed.The cause of the peritonitis or the organism cultured were unknown at the time of follow up.The patient received an intraperitoneal (ip) antibiotic for 2 days; however, the drug and dose were not provided.The porn was uncertain if the patient's cycler was returned to the manufacturer, however the porn stated there was no allegation against the liberty select cycler and/or liberty cycler set having been involved in the event(s).(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: 17532213
• MDR Text Key: 321039940
• Report Number: MW5139121
• 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: 12/07/2020

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