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

Device Problems Malposition of Device (2616); Improper Flow or Infusion (2954)

Patient Problems Bacterial Infection (1735); Peritonitis (2252)

Event Date 07/14/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, a pertoneal dialysis (pd) patient's contact reported to fresenius technical services that the patient was draining slowly during drain 0 of 6.The cycler had reportedly moved into fill after the slow draining in drain 0.During the call, it was reported that the patient had received a new catheter one week prior.Upon follow up, the patient's pd registered nurse (pdrn) reported stated the patient underwent an outpatient pd catheter (not fresenius product) replacement on 14/jul/2020 due to a malposition of the original pd catheter.Prior to this procedure, the patient underwent gastric bypass surgery (unrelated to pd therapy, exact date unknown) and experienced slow drains during ccpd therapy on the liberty select cycler following this event.It was found the patient's pd catheter was sitting too high in the peritoneum as a result of the gatric bypass, whereas the decision was made to replace the catheter.There was no report of hernia, infection or any adverse event that could potentially attribute to the malposition of the patient's pd catheter.It was confirmed the pd catheter replacement was not a result of a malfunction or deficiency of the liberty select cycler or any fresenius product(s) or device(s).The patient was not hospitalized and was recovered from this event.The patient continues ccpd therapy on the same liberty cycler at home.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERITONEAL DIALYSIS (PD) CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17533927
• MDR Text Key: 321170486
• Report Number: MW5140830
• 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: 07/30/2020

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