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

Device Problems Difficult to Flush (1251); Short Fill (1575); Inadequate Ultra Filtration (1656)

Patient Problems Electrolyte Imbalance (2196); Obstruction/Occlusion (2422)

Event Type  Injury  

Event Description

It was reported that during peritoneal dialysis treatment at home on (b)(6) 2016, the patient had draining issues due to the catheter not working properly as the patient was not able to drain or fill adequately.Unsuccessful manual exchanges attempts were made.The patient visited the clinic (b)(6) in (b)(6) center and again attempts to flush the catheter were made however it was challenging to pass fluid through the catheter.Therefore, the patient was sent to the emergency room at (b)(6) medical center, (b)(6) and was admitted to the hospital.It was noted in the labs the patient has high potassium.Patient is currently receiving treatments via hemodialysis.Note: the catheter (unknown manufacturer) is not a fresenius product.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17534771
• MDR Text Key: 321159371
• Report Number: MW5141671
• 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: 05/27/2016

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