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 Problem Peritonitis (2252)

Event Date 08/14/2023

Event Type  Injury  

Event Description

A peritoneal dialysis registered nurse (pdrn)reported that a pd patient was diagnosed with peritonitis.Additional information was obtained through follow-up with the pdrn.The patient was seen in the pd clinic on (b)(6) 2023 for unspecified symptoms.A pd effluent culture was obtained.The patient was diagnosed with peritonitis.The patient was initiated on intraperitoneal (ip) antibiotic therapy (drug, dose, frequency, and duration not provided).The culture was positive for staphylococcus aureus.On (b)(6) 2023 the patient was additionally diagnosed with an exit site infection.The culture from the exit site was positive for pseudomonas (no species provided).The cause of the peritonitis was touch contamination by the patient.The patient continued pd therapy during recovery.The patient did not require hospitalization.The patient completed antibiotic therapy and recovered.

• 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: 19035741
• MDR Text Key: 339286328
• Report Number: 3023981687-2024-00090
• 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: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2024
• 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: 04/03/2024
• Distributor Facility Aware Date: 03/19/2024
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 04/03/2024
• 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
• Patient Age: 61 YR
• Patient Sex: Male