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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/31/2021

Event Type  Injury  

Event Description

It was reported a patient (b)(6) on continuous cyclic peritoneal dialysis (ccpd) for renal replacement therapy (rrt) was taken to the hospital after receiving inadequate pd therapy for approximately a week.Follow-up with the patient's peritoneal dialysis registered nurse (pdrn) confirmed the patient's family member transported the patient to the hospital on (b)(6) 2021 pst, after reportedly receiving inadequate pd therapy for approximately a week.Hematological studies collected in the emergency room (er) confirmed the patient's blood urea nitrogen (bun) and creatinine were elevated (results not provided).The patient was sent for radiological studies (specifics not provided) which revealed the patient's pd catheter (not a fresenius product) had migrated out of the proper position.The patient was admitted and successfully underwent the surgical revision of their pd catheter (not a fresenius product) on (b)(6) 2021.The patient underwent several days of inpatient ccpd therapy to ensure the revised pd catheter (not a fresenius product) was functioning properly, and the patient was discharged in stable condition on (b)(6) 2021.The patient is recovering from the events and resumed utilizing the same liberty select cycler at home following discharge.The pdrn stated the events were unrelated to a fresenius device(s) and/or product(s) malfunction or deficiency.The catheter used by the patient a fresenius device.The manufacturer of the catheter, and further product information, is unknown.(b)(6),(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: 17534333
• MDR Text Key: 321163039
• Report Number: MW5141235
• 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: 03/31/2021

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