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

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Sleep Dysfunction (2517); Constipation (3274)

Event Date 04/08/2023

Event Type  Injury  

Event Description

It was reported that a peritoneal dialysis (pd) patient has been experiencing draining slowly.Issues during drain phase of pd treatment.Draining issues had been occurring for about a month.Patient stated he has been experiencing constipation due to drain complication as well.Pt had to cancel out his treatment several nights due to drain issues; note: patient stated the last time he was able to complete a full treatment on cycler without any issues was mid last month.Pt had an x-ray done and his catheter exit site changed a few days ago.Pt states he does sometimes have constipation and takes over the counter medicine daily for that.Patient expressed he is losing sleep nightly due to this issue.Pt has also expressed they were able to reposition themselves in the past, however repositioning no long effects the drain phase; no issues occurred during fill.Phoned clinic and spoke with (b)(6).Reviewed patient's recent call to ts with pdrn.Pdrn stated that she was aware, as patient has been encountering slow drains for over a week.Per pdrn, patient recently had catheter removed and replaced (different location); however, continues to experience slow drains/drain complications; pdrn did not speak to why patient catheter replaced, but states she "doesn't understand" why patient continues to experience slow drains on the cycler; however, patient is able to do capd without any difficulty.Discussed with pdrn that patient reported to ts that he was constipated.Suggested considering repeat kub; reinforced the importance of resolution of ongoing constipation.Explained that if patient is experiencing chronic constipation then it is likely that patient will continue to experience slow drains/drain complications.Pdrn still focused on patient being able to drain manually.Pdrn stated that she would follow up with patient.Patient able to complete treatment.No adverse events reported.Replacement cycler not necessary.Number: (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: 17488551
• MDR Text Key: 320688313
• Report Number: MW5121250
• 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: 05/16/2023

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