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 01/01/2024

Event Type  Injury  

Event Description

It was reported to fresenius that a peritoneal dialysis (pd patient was in the hospital due to peritonitis.No further details were provided in the initial reporting.Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was hospitalized on an unknown date with a diagnosis of peritonitis.The patient¿s signs and symptoms were not provided.The pd effluent culture resulted positive for staphylococcus aureus.No information pertaining to the antibiotic regimen was provided.The cause of the peritonitis was attributed to touch contamination by the patient.The patient¿s pd catheter was pulled during the hospitalization and the patient was permanently transitioned to hemodialysis (hd).The patient has been discharged from the clinic¿s system; therefore, no additional details pertaining to the hospitalization could be 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: 19160255
• MDR Text Key: 340795619
• Report Number: 3023981687-2024-00101
• 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: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• 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: 04/22/2024
• Distributor Facility Aware Date: 04/01/2024
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 04/22/2024
• Date Manufacturer Received: 04/01/2024
• 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 Sex: Female