MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, SINGLE CONN./EXT. DL; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 050-87216

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

Patient Problems Fatigue (1849); Peritonitis (2252)

Event Date 09/01/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler reported to fresenius customer service she experienced peritonitis.There was no specific allegation this adverse event was due to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Upon follow up with the patient¿s pd registered nurse, it was reported this patient was hospitalized on (b)(6) 2023 following generalized weakness, fatigue and cloudy peritoneal effluent fluid.Peritoneal effluent fluid cultures and a white blood cell (wbc) count taken in the hospital on (b)(6) 2023 presented with aspergillus (species not reported) in the culture and a wbc count of approximately 2500/ml.The patient was diagnosed with peritonitis due to touch contamination during ccpd therapy on the liberty select cycler at home.It was explained the patient was exposed to this peritonitis causing pathogen while gardening and she contaminated her pd catheter during the following pd treatment.The patient was initially given intraperitoneal (ip) vancomycin and ip ceftazidime (dosages and frequency unknown) for antibiotic therapy, as well as other fungicide medications (types, routes, dosages, and frequency unknown) during this admission.The patient was able to undergo ccpd therapy on a hospital provided baxter cycler (not a fresenius product) until her pd catheter (not a fresenius product) was removed due to the severity and nature of this infection.The patient was transitioned to hemodialysis (hd) for renal replacement therapy on a hospital provided hd device (unknown brand and model) for the duration of the admission.The patient has experienced a difficult hospital course as she is on immunosuppressive therapy following a kidney transplant in (b)(6) 2023, which has complicated this infection and promoted sepsis.The patient is recovering from this event while awaiting discharge home.It was confirmed the patient¿s peritonitis, and the associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient plans to continue hd therapy on an in-center basis upon discharge.

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 17802382
• MDR Text Key: 324112867
• Report Number: 3023981687-2023-00212
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87216
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/22/2023
• Distributor Facility Aware Date: 09/12/2023
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 09/22/2023
• Date Manufacturer Received: 09/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY SELECT CYCLER
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 65 KG