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 Pneumonia (2011); Urinary Tract Infection (2120); Peritonitis (2252)

Event Date 07/26/2023

Event Type  Injury  

Event Description

A peritoneal dialysis registered nurse [(pd)rn] reported that this pd patient was hospitalized for peritonitis and pneumonia.Additional information was obtained through follow-up with the pdrn.The patient was admitted to the hospital on (b)(6) 2023.The admitting diagnosis was peritonitis, urinary tract infection (uti), and pneumonia.The patient was severely constipated at the time of hospitalization.There is no information related to pd effluent culture results or antibiotic therapy.Additionally, there is no information related to the uti or pneumonia.The patient was discharged on (b)(6) 2023 and has transitioned to in-center hemodialysis.The patient¿s son reported that the patient was cleaning their pd exit site and catheter a different way.This is believed to be the cause of the peritonitis event; however, it was not confirmed.No additional information was provided.

• 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: 17482637
• MDR Text Key: 320654390
• Report Number: 3023981687-2023-00155
• 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: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• 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: 08/08/2023
• Distributor Facility Aware Date: 08/07/2023
• Device Age: MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2023
• Date Manufacturer Received: 08/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY SELECT CYCLER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female