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

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Fresenius became aware through a survey that this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler underwent bariatric surgery and was transitioned to hemodialysis (hd) that required additional surgery.There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon follow up with the patient's pd registered nurse, it was reported this patient underwent bariatric surgery for a gastric sleeve placement for weight loss on (b)(6) 2020 (event captured and investigated in file (b)(4)).It was determined pd therapy was contraindicated following the bariatric surgery by the patient's physician.As a result, the patient underwent a preemptive outpatient surgical procedure on (b)(6) 2021 for a pd catheter (not a fresenius product) removal and central vascular catheter placement in order to transition from pd to hd for renal replacement therapy.The patient continued with in-center hemodialysis following this surgical procedure.It was confirmed the patient's outpatient procedures for a pd catheter removal and central vascular catheter placement were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient had their pd catheter replaced and resumed ccpd therapy on the same liberty select cycler in (b)(6) 2021.Based on the required information, there is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue.(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: 17525221
• MDR Text Key: 321520011
• Report Number: MW5132162
• 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: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1