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

Device Problems Display or Visual Feedback Problem (1184); Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that a peritoneal dialysis (pd) patient discovered fluid leaking from the connection of the patient's baxter solution bag to safe lock apo luer lock connector after ending their pd treatment.The patient reported receiving an air detected in cassette alarm during dwell 4 of 4 of treatment.It is unknown at which point in therapy the leak may have begun.The cause of the leak is unknown.Fluid was not discovered within the pump module area of the cycler, and no fluid was found on the external of the cassette.The patient was advised to discontinue the use of their cycler and follow up with their peritoneal dialysis nurse (porn).A new cycler was issued to the patient.It was reported that an alternate treatment option was available.Upon follow up the porn declined to provide additional information.Additional information has been requested but to date has not been provided.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERITONEAL DIALYSIS
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17522511
• MDR Text Key: 321447427
• Report Number: MW5129459
• 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: 04/14/2022

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