MAUDE Adverse Event Report: UNKNOWN PERITONEAL DIALYSIS CATHETER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Device Problems Malposition of Device (2616); No Flow (2991)

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

Event Type  Injury  

Event Description

On (b)(6) 2023, during a follow up, this male peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler reported to fresenius he was hospitalized due to his pd catheter (not a fresenius product) not working properly.There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon follow up with the patient's pd registered nurse, it was reported this patient was hospitalized on (b)(6) 2023 for drain complications caused by issues with his pd catheter (not a fresenius product).It was explained that the patient's pd catheter was found in malposition during this admission.It was affirmed that the patient did not experience a serious injury that could have potentially caused or contributed to the malposition of his pd catheter.The patient's pd catheter was removed, and a central vascular catheter was placed in favor of hemodialysis (hd) for renal replacement therapy.The patient underwent hd therapy on a hospital provided hd machine (unknown brand and model) for the duration of the admission.The patient recovered from this event and was discharged home on (b)(6) 2023.It was confirmed that the patient's drain complications caused by a malposition of his pd catheter, and the associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continues hd therapy on in-center basis post-discharge with no plan to return to pd therapy.File#: (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: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17488555
• MDR Text Key: 320699823
• Report Number: MW5121254
• Device Sequence Number: 1
• Product Code: FKX
• 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: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1