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

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682)

Patient Problem Swelling/ Edema (4577)

Event Type  Injury  

Event Description

On (b)(6) 2023, during a follow up, this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler reported to fresenius he was hospitalized for swelling due to pd catheter (not a fresenius product) complications.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 underwent an outpatient procedure on (b)(6) 2023 for a pd catheter (not a fresenius product) revision.It was explained the patient previously experienced drain complications during ccpd therapy on the liberty select cycler at home due to a malposition of his pd catheter.It was affirmed the patient did not experience a serious injury or adverse event that could have potentially caused or contributed to the malposition of his pd catheter.The patient was not hospitalized for this event and was released to home following the procedure.The patient experienced swelling around the surgical site of the catheter revision on (b)(6) 2023.The patient presented to the hospital on (b)(6) 2023 and was admitted on the same day for observation.The patient¿s swelling was due to an adverse reaction of the surgery whereas the patient had non-infectious swelling due to third spacing of internal blood lost during the procedure.The patient was able to undergo ccpd therapy on a hospital provided liberty cycler for the duration of the admission.The patient had an uneventful hospital course and was discharged to home on (b)(6) 2023.It was confirmed the patient¿s malposition of his pd catheter, the resulting outpatient surgical procedure, localized edema, and associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient is recovering from these events and continues ccpd therapy on the same liberty select cycler at home post-discharge.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
• MDR Report Key: 17435379
• MDR Text Key: 320257559
• Report Number: MW5120403
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1