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 Diarrhea (1811); Peritonitis (2252)

Event Date 04/15/2024

Event Type  Injury  

Event Description

On (b)(6) 2024 this peritoneal dialysis (pd) patient contacted fresenius technical support for draining slowly messages over the last week during treatment on the liberty select cycler.The patient advised she was diagnosed with an infection and was started on antibiotics.Additional information was obtained through follow-up with the patient.The patient stated the unspecified infection was peritonitis.The patient was being treated with antibiotics.The patient also reported that on (b)(6) 2024 she had the pd catheter (not a fresenius product) replaced.Further details pertaining to the patient¿s peritonitis event were obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient presented to the pd clinic on (b)(6) 2024 with cloudy pd fluid and complaints of diarrhea.A pd effluent culture was obtained.The patient was initiated on intraperitoneal (ip) antibiotics (drug, dose, frequency, and duration not provided).The patient was diagnosed with peritonitis.The patient¿s white blood cell count (wbc) was elevated to 2,844.After five days, the pd culture shows no organism growth, but a high white cell count.The cause of the peritonitis is unknown.The only issue the patient reported was poor drains.The patient had a pd catheter (not a fresenius product) revision (not a replacement as the patient reported) completed on (b)(6) 2024.The patient did not report any fluid leak or other issue with the liberty select cycler or cycler set related to this event.

• 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: 19174819
• MDR Text Key: 340952566
• Report Number: 3023981687-2024-00104
• 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: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/24/2024
• Distributor Facility Aware Date: 04/18/2024
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 04/24/2024
• Date Manufacturer Received: 04/18/2024
• 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: 64 YR
• Patient Sex: Female