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

Device Problems Failure to Advance (2524); Malposition of Device (2616)

Patient Problem Hypervolemia (2664)

Event Date 03/12/2022

Event Type  Injury  

Event Description

It was explained the patient's pd catheter (not a fresenius product) was found in malposition which caused drain complications during continuous cyclic pd (ccpd) therapy on the liberty select cycler at home, directly attributing to his fluid overload.It was affirmed the patient did not experience fluid overload on or around the time of a ccpd treatment; however, it was stated due to the drain complications, the fluid build-up was cumulative.The patient's pd catheter was repositioned while he was hospitalized, and the patient was able to continue ccpd therapy on a hospital provided cycler (unknown brand and model) for the duration of the admission.The patient had an uneventful hospital course and was discharged to home on (b)(6) 2022.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERITONEAL DIALYSIS CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17535691
• MDR Text Key: 321156013
• Report Number: MW5142586
• 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: 03/29/2022

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