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

Device Problem Malposition of Device (2616)

Patient Problems Hernia (2240); Hypervolemia (2664)

Event Date 09/07/2020

Event Type  Injury  

Event Description

A registered nurse {rn} reported that a peritoneal dialysis {pd} patient will be performing continuous ambulatory peritoneal dialysis (capd) because they have been experiencing issues draining on cycler while in the laying down position.The rn reported that the issue has been occurring for an unknown amount of time now, but was not a high concern as the patient was still urinating independently.The rn reported that the patient's urine levels have decreased recently and the patient experienced a fluid overload at 10kg over dry-weight on 9ll/2020.The rn reported that the initial plan was to pull more fluids with throughout the day.However, the rn reported that the patient drained just fine with capd, and the patient does not want to reposition their catheter.Upon follow up, the patient's peritoneal dialysis registered nurse (pdrn) reported this patient experienced persistent drain complications during continuous cyclic peritoneal dialysis (ccpd) therapy on the liberty select cycler at home while in the supine position.The patient also experienced fluid overload on 9ll /2020 directly attributed to drain complications due to a malposition of the patient's pd catheter {not a fresenius product).Due to the malposition of the patient's pd catheter, the patient has been forming an umbilical hernia over time.The patient has not experienced any pain as a result of these events and ccpd therapy on the liberty select cycler has not exacerbated the severity of the hernia, as the hernia is directly attributed to the malposition of the pd catheter.The patient was not hospitalized and no additional medical intervention beyond ongoing pd therapy support was provided.There was no report this event was due to a deficiency or malfunction of the liberty select cycler or any fresenius product(s) or device(s).The patient has refused surgery to reposition their pd catheter and has transitioned to capo as the patient has not experienced drain complications with capo.The patient continues capo therapy at home with no plans to continue ccpd therapy on the liberty select cycler.(b)(4).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
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17534233
• MDR Text Key: 321161756
• Report Number: MW5141136
• 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: 10/02/2020

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