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 Peritonitis (2252); Fungal Infection (2419)

Event Date 03/15/2024

Event Type  Injury  

Event Description

On 22/mar/2024, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a liberty select cycler and liberty cycler set for renal replacement therapy (rrt) was hospitalized due to hypotension, shortness of breath (dyspnea), and confusion.No additional information was provided during intake.During follow-up, the patient¿s pd registered nurse (pdrn) confirmed the patient presented to the outpatient home dialysis clinic on (b)(6) 2024 for his monthly appointment with his nephrologist.While checking the patient in, it was noted the patient was hypotensive, confused, and dyspneic.The patient was sent to the emergency room from the outpatient dialysis clinic via emergency medical services.The patient was admitted for chronic obstructive pulmonary disease (copd) exacerbation due to asthma and was successfully treated with steroids (confusion and dyspnea abated).While admitted it was noted the patient¿s peritoneal effluent fluid was cloudy on (b)(6) 2024, and a peritoneal effluent fluid culture and cell count (wbc = elevated, value unknown) were collected.The patient was subsequently diagnosed with peritonitis and was treated with intraperitoneal (ip) vancomycin 1500 mg and ceftazidime 1500 mg daily.However, on (b)(6) 2024 the preliminary peritoneal effluent fluid cultures were positive for candida (genus unknown) and the attending nephrologist ordered the removal of the patient¿s pd catheter, while simultaneously receiving a tunneled hemodialysis (hd) catheter (not a fresenius product).The patient¿s antibiotic regimen remains unchanged; however, it is now being administered intravenously (iv) during hd therapy.The pdrn attributed causality to the patient wearing his cpap mask instead of a ¿yellow¿ mask causing air to blow directly at the pd catheter (not a fresenius product) during initiation and termination of treatment.Per the pdrn, the events were unrelated to the patient¿s utilization of any fresenius product(s) and/or device(s).The pdrn stated the patient¿s hypotension resolved without any direct medical intervention once the patient¿s peritonitis, asthma, and copd exacerbation were treated.The patient currently remains hospitalized and is recovering from the serious adverse events.

• 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: 19003478
• MDR Text Key: 338901175
• Report Number: 3023981687-2024-00086
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100750
• UDI-Public: 00840861100750
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• 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: 03/29/2024
• Distributor Facility Aware Date: 03/22/2024
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 03/29/2024
• Date Manufacturer Received: 03/22/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID.; LIBERTY SELECT CYCLER.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 91 KG