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

Device Problems Malposition of Device (2616); Noise, Audible (3273)

Patient Problem Pain (1994)

Event Date 04/01/2021

Event Type  Injury  

Event Description

On 1 0/jul/2021 the patient contact of this male peritoneal dialysis (pd) patient contacted fresenius customer service.The patient contact reported the patient was draining too fast which caused pain during the drain cycler while utilizing the liberty select cycler.A computed tomography (ct) scan was done, and it was determined the peritoneal dialysis (pd) catheter was malpositioned.The patient contact stated the malposition was caused by the liberty select cycler.According to the patient's peritoneal dialysis registered nurse (pdrn), the event occurred in april.Additional information was obtained through follow-up with the pdrn.The patient was in treatment on an unknown date in (b)(6) 2021 when the liberty select cycler began getting noisy.The patient began to drain too fast, and experience drain pain.The pdrn stated the liberty select cycler did not alarm.The treatment records were reviewed by the pdrn and there were no issues with the liberty select cycler prior to the draining too fast.The patient went for a ct scan (unknown date) and the pd catheter (not a fresenius product) was found to be malpositioned.On (b)(6) 2021 the patient underwent a pd catheter revision.The procedure was done in an outpatient setting.The patient continued to complete pd therapy utilizing the liberty select cycler after the revision.No additional information was provided.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17534902
• MDR Text Key: 321148596
• Report Number: MW5141802
• 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: 07/22/2021

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