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

Device Problems Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was reportedly hospitalized for 2-3 weeks while undergoing several unsuccessful pd catheter (not a fresenius product) revisions.Follow-up with the patient's pd registered nurse (porn) revealed the patient was evaluated at the outpatient dialysis clinic due to drain complications.While at the clinic, the patient's pd catheter (not a fresenius product) extension set was changed to evaluate if it would improve the pd catheter's function.However, the patient was still experiencing drain complications and was sent to the emergency room (er) for further evaluation.Radiological studies (specifics not provided) revealed the patient's pd catheter had migrated out of the proper position.The patient was admitted and successfully underwent the surgical revision of their pd catheter.The patient underwent several days of inpatient ccpd therapy to ensure the revised pd catheter was functioning properly, and the patient was discharged in stable condition.The patient is recovering from the events and resumed utilizing the same liberty select cycler at home following discharge.The porn stated there was no malfunction or deficiency of a fresenius device(s) and/or product(s) which occurred.Additionally, the patient was evaluated in the clinic for their monthly visit and reported their pd catheter was working well.The patient's daughter correctly reported the patient's pd catheter was revised twice in 7 days; however, the patient was only hospitalized for 5 days (daughter reported 2-3 weeks during intake).(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: 17524593
• MDR Text Key: 321135428
• Report Number: MW5131539
• 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: 04/02/2021

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