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 Cardiac Arrest (1762); Pneumonia (2011); Sepsis (2067); Peritonitis (2252); Respiratory Failure (2484)

Event Date 09/09/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, a patient care technician (pct) reported to fresenius customer service this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler was hospitalized with peritonitis and expired during this admission.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 reporting pct and the patient¿s pd registered nurse, it was reported this patient was hospitalized on (b)(6) 2023 following abdominal pain and cloudy peritoneal effluent fluid.The patient also received diagnoses of aspiration pneumonia, respiratory failure, multi-organ failure and sepsis, all of which were attributed to chronic comorbidities and unrelated to pd therapy or the use of any fresenius product(s) or device(s).Peritoneal effluent fluid cultures and a white blood cell (wbc) count taken in the hospital on (b)(6) 2023 presented with staphylococcus epidermidis in the culture and an elevated wbc count (exact count unknown).The patient was diagnosed with peritonitis due to a break in aseptic technique during ccpd therapy on the liberty select cycler at home.It was explained the patient had issues with cleanliness and did not always adhere to handwashing protocol during pd treatments.The patient was prescribed intravenous (iv) vancomycin, iv gentamycin and iv ciprofloxacin for antibiotic therapy (unknown dosages, frequency and durations).The patient¿s pd catheter was removed due to the severity and nature of infection during this hospitalization.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 treatment course.On (b)(6) 2023, due to the severity of the patient¿s multimorbidity, the patient was placed on ¿comfort measures only¿ (cmo) which discontinued all modalities of renal replacement therapy.The patient expired on (b)(6) 2023 due to a cardiac arrest attributed to multi-organ failure.It was affirmed the patient was not on any modality of dialysis at the time of death and lifesaving measures were not performed due to the cmo order.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).Additionally, it was confirmed the patient¿s cardiac arrest, attributed to multi-organ failure and their subsequent death was unrelated to renal replacement therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).

• 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: 17992736
• MDR Text Key: 326349139
• Report Number: 3023981687-2023-00246
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/23/2023
• Distributor Facility Aware Date: 10/09/2023
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 10/23/2023
• Date Manufacturer Received: 10/09/2023
• 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: 58 YR
• Patient Sex: Female