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

Device Problems Partial Blockage (1065); Appropriate Term/Code Not Available (3191)

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

Event Date 12/07/2020

Event Type  Injury  

Event Description

It was reported that a peritoneal dialysis (pd) patient was undergoing surgery for a pd catheter.Upon follow-up, the patient's pd registered nurse (pdrn) confirmed the patient underwent an outpatient pd catheter (not a fresenius product) revision.The patient was experiencing drain complications and was sent for radiological studies on (b)(6) 2020.X-rays showed the patient's pd catheter had become intertwined with the bowel and was partially obstructed.The patient successfully underwent the pd catheter revision and while in surgery, the patient received a temporary hemodialysis (hd) catheter (not a fresenius product) and transitioned to "back-up" hd therapy for 14 days to allow the patient's abdomen to heal properly.The patient has tolerated the transition well and is recovering from the events.The pdrn stated the events were unrelated to the utilization of any fresenius device(s), and/or product(s).Once the patient's abdomen is healed, the patient will resume utilizing the same liberty select cycler as before the events.Based on the available information, the patient's liberty select cycler is disassociated from the events.There is no allegation or objective evidence indicating a serious injury, patient death, or other serious adverse event(s) related to a fresenius device(s) or product(s) occurred warranting further investigation.The catheters used by the patient are not fresenius devices.The manufacturer of the catheters, and further product information, are unknown.(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: 17526188
• MDR Text Key: 321135228
• Report Number: MW5133128
• 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: 12/16/2020

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