MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, DUAL PATIENT CONNECT; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 050-87212

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

Patient Problems Abdominal Pain (1685); Low Blood Pressure/ Hypotension (1914); Peritonitis (2252)

Event Date 03/05/2024

Event Type  Death  

Event Description

On 26/mar/2024, it was reported by a registered nurse (rn) that this patient on peritoneal dialysis (pd) was hospitalized with peritonitis.In additional follow-up, the patient¿s pd nurse stated the patient was experiencing symptoms of abdominal pain.As a result, on (b)(6) 2024, the patient was initially seen in the outpatient pd clinic and had a pd culture obtained.Per the nurse, the pd culture was positive for the bacteria staphylococcus epidermis.The patient was initiated on intra-peritoneal (ip) vancomycin and ceftazidime (per clinic protocol).Subsequently, on (b)(6) 2024, the patient had low blood pressure (reading not provided) while being seen at the outpatient pd clinic for a second dose of ip antibiotics.Per the nurse, the patient was hospitalized (the same day) for the issue of low pressure.While hospitalized, the patient continued antibiotic therapy (details unknown).The nurse stated the patient¿s peritonitis infection was cleared in the hospital.However, the nurse stated the patient¿s overall health had been declining over the past year and that the patient had failure to thrive and was not eating or drinking in the hospital.Subsequently, on an unknown date while hospitalized, the patient expired.The patient¿s pd nurse stated the patient¿s low pressure was not related to pd therapy.The nurse indicated the event was caused by the medication amiodarone that the patient was started on for atrial fibrillation.Additionally, the pd nurse confirmed the patient did not have any fluid leaks or issues with fresenius products in relation to the peritonitis and fluid overload event.The nurse indicated the peritonitis was due to a breach in aseptic technique during the pd exchange whereby the patient was not wearing a mask.Furthermore, the nurse indicated the exact cause of death was unknown.However, it was reported that the death did not occur during a pd treatment and was not related to fresenius products.

• Brand Name: LIBERTY CYCLER SET, DUAL PATIENT CONNECT
• 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: 19061303
• MDR Text Key: 339638952
• Report Number: 3023981687-2024-00091
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100736
• UDI-Public: 00840861100736
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87212
• 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: 04/08/2024
• Distributor Facility Aware Date: 03/26/2024
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 04/08/2024
• Date Manufacturer Received: 03/26/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY SELECT CYCLER
• Patient Outcome(s): Required Intervention; Death; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female