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 Abdominal Pain (1685); Peritonitis (2252)

Event Date 01/25/2024

Event Type  Injury  

Event Description

A peritoneal dialysis registered nurse (pdrn) reported that the patient is a bedbound patient and was not hospitalized but visited the emergency room (er) on (b)(6) 2024.The patient was experiencing hypotension for some time and was being treated with midodrine medication.The pdrn confirmed that none of the events were related to the pd therapy or the use of fresenius products.She stated that the patient was doing well and continuing with pd treatment.While on the call, the pdrn stated that the patient was hospitalized in february for peritonitis, but she had no further information about the event.Upon follow up, it was reported this patient was hospitalized on (b)(6) 2024 following abdominal pain and cloudy peritoneal effluent fluid.Peritoneal effluent fluid cultures and a white blood cell (wbc) count taken in the hospital on (b)(6) 2024 presented with no growth in the culture and a wbc count of 612/mm3.The patient was diagnosed with peritonitis due to unknown etiology.The patient was prescribed intraperitoneal (ip) vancomycin at 2000 mg and ip ceftazidime at 2000 mg (frequency and duration not reported) to address the infection.It was believed the patient was able to undergo ccpd therapy on a hospital provided cycler for the duration of the admission.The patient had an uneventful hospital course and was discharged to home on (b)(6) 2024.It was confirmed, though the exact cause of this adverse event remains unknown, there was no indication the patient¿s peritonitis, and the associated hospitalization were due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient recovered from this event as he remains asymptomatic and continues ccpd therapy on the same liberty select cycler at home post-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: 19003024
• MDR Text Key: 338891592
• Report Number: 3023981687-2024-00085
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/28/2024,03/29/2024

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/28/2024
• Distributor Facility Aware Date: 03/19/2024
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 03/28/2024
• Date Manufacturer Received: 03/19/2024
• 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; Hospitalization
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 86 KG