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

Device Problems Display or Visual Feedback Problem (1184); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that a peritoneal dialysis (pd) patient discovered a fluid leak from at the patient's catheter and stay-safe connector connection during fill 1 of 3 of their pd treatment.The patient contact reported receiving a patient line is blocked alarm during their 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 in the pump module area or on the external of the cassette.The patient was advised to follow up with their peritoneal dialysis nurse (pdrn).Upon follow up, the pdrn stated the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and confirmed that the patient was able to complete peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd) in the absence of the cycler.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The pdrn stated that the fluid leak occurred from the cassette and did not come in contact with the cycler.The patient is continuing peritoneal dialysis therapy with no further issues.The cassette used by the patient was discarded and is not available for return for physical evaluation by the manufacturer.(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: 17524658
• MDR Text Key: 321436202
• Report Number: MW5131603
• 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: 04/05/2022

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