MAUDE Adverse Event Report: UNKNOWN; FRESENIUS MEDICAL CARE 1. PD CATHETER; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Device Problems Improper Flow or Infusion (2954); Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis (ccpd) for renal replacement therapy (rrt) was experiencing drain complications.According to the patient's son, the patient underwent a pd catheter (not a fresenius product) revision and the catheter is functioning appropriately while performing manuals.However, when the patient utilizes the liberty select cycler they encounter the same drain complications as before surgery.Follow-up with the clinic's pd registered nurse ("pdrn") confirmed the patient underwent a pd catheter (not a fresenius product) revision and following surgery continued to experience drain complications.The pdrn reported they evaluated the patient's pd catheter post-surgery and confirmed it functioned appropriately during manual therapy.However, when utilizing the liberty select cycler the patient continued to experience drain complications.The pdrn attributed causality to the liberty select cycler based on the patient being issued a replacement liberty select cycler (captured in file (b)(4)), after which the drain complications resolved.The patient's liberty select cycler is scheduled to be picked up via fedex today.Additional information was requested (e.G., discharge summary, surgical report, treatment data, demographics), however the pdrn declined.(b)(4) this report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: 1. PD CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN; FRESENIUS MEDICAL CARE
• MDR Report Key: 17528843
• MDR Text Key: 321092388
• Report Number: MW5135773
• 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: 04/28/2021

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
• Treatment: FKX