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

Device Problems Migration or Expulsion of Device (1395); Infusion or Flow Problem (2964)

Patient Problems Adhesion(s) (1695); Pain (1994)

Event Type  Injury  

Event Description

On (b)(6) 2022 during follow-up, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) underwent surgery (specifics not provided) on (b)(6) 2022 due to drain pain and drain complications.Follow-up with the patient's pd registered nurse (pdrn) revealed the patient's pd catheter (not a fresenius product) was surgically placed on (b)(6) 2022 without reported issue.The patient began experiencing drain complications later the same month and was sent to the surgeon on (b)(6) 2022 for evaluation.The surgeon felt the pd catheter may have migrated out of position, and the patient was scheduled for exploratory pd catheter surgery on (b)(6) 2022.During surgery it was discovered the patient had several adhesions which were obstructing the flow of solution.The surgeon repositioned the tip of the pd catheter with good success, and the patient resumed ccpd therapy the same evening without issue.The patient continues to undergo ccpd therapy utilizing the same liberty select cycler and has recovered from the events.The pdrn reported the events were unrelated to the patient's utilization of any fresenius product(s) and/or device(s).It was reported the adhesions were a complication of the initial pd catheter placement.(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: 17488360
• MDR Text Key: 320690818
• Report Number: MW5121059
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1