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 03/13/2024

Event Type  Injury  

Event Description

On (b)(6) 2024 a delivery driver reported that this male peritoneal dialysis (pd) patient was not at home due to being treated for peritonitis at the pd clinic.Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was seen at the pd clinic on (b)(6) 2024 for symptoms of abdominal pain and cloudy pd effluent.A pd effluent culture was obtained.The patient was diagnosed with peritonitis and initiated antibiotic therapy with intraperitoneal (ip) vancomycin (dose, frequency, and duration not provided).The pd effluent culture resulted positive on (b)(6) 2024 for corynebacterium species.The patient did not require hospitalization for the event.The cause of the peritonitis was attributed to touch contamination by the patient.The patient is continuing to complete pd therapy utilizing the liberty select cycler during recovery.

• 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: 18950784
• MDR Text Key: 338255347
• Report Number: 3023981687-2024-00080
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/21/2024
• Distributor Facility Aware Date: 03/13/2024
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 03/21/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2024
• 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: 47 YR
• Patient Sex: Male