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

Device Problems Malposition of Device (2616); Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 08/01/2020

Event Type  Injury  

Event Description

It was reported that a peritoneal dialysis (pd) patient was hospitalized.There was no specific allegation this event was related to a deficiency or malfunction of any frenenius device(s) or product(s) in the initial reporting.Upon follow up, the patient's pd registered nurse (pdrn) reported this patient underwent an outpatient pd catheter (not a fresenius product) replacement on 08/01/2020.The patient's pd catheter had migrated into malpostion within the peritoneum which caused complications (excat complications not specified) during continuous cyclic pd (ccpd) therapy on the liberty select cycler.The patient was not hospitalized for this event.The patient did not experience an infection, a hernia or any adverse event that could have contributed to the malposition of the pd catheter.It was confirmed the malposition of the patient's pd catheter and the associated outpatient pd catheter replacement were not due to a deficiency or malfunction of the liberty select cycler or any fresenius device(s) or product(s).The patient is recovering from this event and has temporarily transitioned to outpatient hemodialysis therapy for two weeks to allow the pd catheter entry site to heal.The patient plans to continue ccpd therapy on the same liberty select cycler at home when appropriate.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERITONEAL CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17535740
• MDR Text Key: 321154492
• Report Number: MW5142634
• 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: 09/09/2020

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