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

Device Problem Obstruction of Flow (2423)

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

Event Date 02/15/2021

Event Type  Injury  

Event Description

It was reported that a patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) underwent outpatient pd catheter (not a fresenius product) surgery on (b)(6) 2021.Follow-up with the patient's pd registered nurse (porn) revealed the patient underwent an x-ray and a computed tomography (ct) scan, due to reported drain complications.Additionally, the patient was reportedly treated with heparin, alteplase, and a single dose of intraperitoneal (ip) vancomycin i 000 mg.The patient continues to undergo ccpd therapy and is recovering from the events.The pdrn stated the events were unrelated to the use of any fresenius device.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.(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: 17529858
• MDR Text Key: 321135963
• Report Number: MW5136781
• 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: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1