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 surgery following a transition from pd to hemodialysis (hd) for renal replacement therapy.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 was transitioned from pd to hd for renal replacement therapy per physician direction following bariatric surgery, whereas the patient's pd catheter (not a fresenius product) was removed.It was determined the patient could return to pd therapy in (b)(6) 2021.The patient underwent an outpatient surgical procedure for pd catheter placement on (b)(6) 2021.It was confirmed the patient's outpatient procedure for pd catheter placement was not due to a deficiency or malfunction of any fresenius product(s) or device(s).Additionally, it was affirmed the patient did not experience a serious injury or adverse event due to this procedure.The patient resumed ccpd therapy on the same liberty select cycler at home following these events.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: 17524251
• MDR Text Key: 321410422
• Report Number: MW5131198
• 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

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