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 Peritonitis (2252); Malaise (2359)

Event Date 02/12/2024

Event Type  Injury  

Event Description

During a follow-up call for a heater bag not detected message, this peritoneal dialysis (pd) patient stated she was admitted to the hospital on (b)(6) 2024.The patient stated she was unsure if the hospitalization was related to the liberty select cycler, but something had happened to her pd catheter incision.Additional information was provided by the patient¿s peritoneal dialysis registered nurse (pdrn).The patient arrived at the hospital on (b)(6) 2024 with complaints of general malaise.The patient was admitted to the hospital.The pdrn stated she was initially informed the patient was diagnosed with sepsis based on positive blood culture results.The pdrn was then updated on the patient¿s status and informed the patient was also diagnosed with peritonitis.No culture results were available to the pdrn as no hospital documentation has been received.The pdrn stated the patient has a history of diverticulitis and without culture results could not confirm if the peritonitis and subsequent sepsis was caused by the diverticulitis or due to another cause.The pdrn had no additional information related to the patient¿s hospitalization.The patient¿s report of something happening to the pd catheter incision could not be confirmed.

• 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: 18790453
• MDR Text Key: 336355102
• Report Number: 3023981687-2024-00064
• Device Sequence Number: 1
• Product Code: FKX
• 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: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• 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: 02/27/2024
• Distributor Facility Aware Date: 02/19/2024
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 02/27/2024
• Date Manufacturer Received: 02/19/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY SELECT CYCLER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female