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

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported that peritoneal dialysis (pd) patient discovered a fluid leak from their catheter during dwell 1 of 4 of their pd treatment.It is unknown at which point in therapy the leak may have begun.The cause of the leak is unknown.The fluid leak did not come in contact with their cycler.The patient's treatment was cancelled.It was reported that an alternate treatment option was available.Upon follow up, the home therapies program manager (htpm) stated the patient woke up in the middle of the night to a soaking wet bed and carpet.After checking the patient line, the patient realized fluid was leaking from the blue patient line connection, where it connects to the catheter.The htpm stated there were no reported machine alarms that occurred during the treatment.The patient was in dwell 1 of 4 when the fluid leak was discovered.The patient ended their treatment and id not re-setup with new supplies.The patient did not perform a manual pd exchange.The htpm stated the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.As a precaution, prophylactic antibiotics were prescribed to the patient.The patient was prescribed keflex oral tablets, 250 mg, to be taken 3 times per day for 5 days.The patient is continuing peritoneal dialysis therapy with no further issues.It was unknown it the liberty cycler set used by the patient is available for return for physical evaluation by the manufacturer.(b)(6), (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERITONEAL CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17533725
• MDR Text Key: 321158383
• Report Number: MW5140629
• 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: 09/08/2020

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