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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sepsis (2067)

Event Date 12/15/2021

Event Type  Death  

Event Description

On 7/mar/2022, a patient contact reported to fresenius technical services this 56-year-old female peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler expired.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 expired at home on (b)(6)2021 due to complications with bladder cancer.The patient was initially admitted to the hospital in (b)(6) 2021 (exact date unknown) and had a complicated, lengthy hospital stay due to sepsis and bladder cancer.It was affirmed the patient's bladder cancer and sepsis were unrelated to pd therapy or the use of any fresenius product(s) or device(s).The patient was able to undergo ccpd therapy on a hospital provided cycler (unknown brand and model) until the patient was placed on hospice in early (b)(6) 2021 (exact date unknown).The patient's pd catheter (not a fresenius product) was removed during this admission and all modalities of dialysis were discontinued due to the hospice order.The patient was discharged from the hospital on (b)(6)2021 and they expired the following day at home.Emergency services were not activated and no life saving measures were performed due to the hospice order.It was reported the patient was not undergoing any modality of dialysis on or around the time of their death.Additionally, it was confirmed the patient's hospitalization, sepsis and death due to complications with bladder cancer were unrelated to pd therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).C-913551, (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERITONEAL DIALYSIS CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17524519
• MDR Text Key: 321042799
• Report Number: MW5131465
• 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: 03/22/2022

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