MAUDE Adverse Event Report: UNKNOWN CENTRAL VASCULAR CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Device Problems Obstruction of Flow (2423); Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Event Description

Fresenius became aware through a survey that this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler underwent surgery following a transition from pd to hemodialysis (hd) for renal replacement therapy.There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon follow up with the patient's pd registered nurse, it was reported this patient was transitioned from pd to hd for renal replacement therapy per physician direction following bariatric surgery.Along the course of in-center hd therapy, the patient's central vascular catheter (not a fresenius product) was found to be obstructed by a clot that could not be cleared in the dialysis clinic (exact date unknown).The patient underwent an outpatient nonemergent central vascular catheter exchange on (b)(6) 2021.It was confirmed the patient did not experience a serious injury or adverse event as a result of the obstructed central vascular catheter.Additionally, it was affirmed the obstructed central vascular catheter and the associated procedure were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continued in-center hd therapy following this event.The patient had their pd catheter replaced and resumed ccpd therapy on the same liberty select cycler in (b)(6) 2021.Based on the required information, there is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CENTRAL VASCULAR CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17524626
• MDR Text Key: 321409271
• Report Number: MW5131572
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 06/23/2021

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