MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, DUAL PATIENT CONNECT; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 050-87212

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Peritonitis (2252); Malaise (2359)

Event Date 03/18/2024

Event Type  Injury  

Event Description

A peritoneal dialysis registered nurse (pdrn) reported that the patient was hospitalized on 03/18 and diagnosed on 3/19 for peritonitis.Upon additional follow-up, the patient¿s pdrn reported that the patient was hospitalized on (b)(6) 2024 for malaise.During hospitalization, on (b)(6) 2024, the patient had a pd culture obtained which generated an elevated white blood cell (wbc) count.The patient was treated with intravenous (iv)antibiotic therapy using ceftazidime and vancomycin (dose unknown).Per the nurse, it was also discovered that the patient¿s pd catheter (not a fresenius product) had stopped working.As a result, the patient was transitioned to hemodialysis for renal replacement needs.At the time follow-up was performed, the patient remained in the hospital recovering from the event.Per the nurse, the patient did not have any fluid leaks or any issues with fresenius device, or product in relation to the event.The nurse indicated the patient had concomitant constipation.Additionally, the nurse stated the patient has pre-existing and ongoing confusion due to disease process.The nurse reported that the peritonitis event was likely due to patient error (in setting of pre-existing confusion) combined with concomitant constipation.

• Brand Name: LIBERTY CYCLER SET, DUAL PATIENT CONNECT
• 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: 19027559
• MDR Text Key: 339184486
• Report Number: 3023981687-2024-00088
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100736
• UDI-Public: 00840861100736
• 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: 04/02/2024

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: 050-87212
• 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: 04/02/2024
• Distributor Facility Aware Date: 03/20/2024
• Device Age: MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/02/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2024
• 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 Age: 74 YR
• Patient Sex: Female