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 02/02/2024

Event Type  Injury  

Event Description

It was reported that this patient on peritoneal dialysis (pd) therapy had an event of peritonitis.There were no reported allegations that the event was related to any issues with fresenius products.In additional follow-up, the patient¿s pd nurse reported that the patient had peritonitis on (b)(6) 2024.The nurse clarified that the patient was seen in the emergency room (er) on (b)(6) 2024 for a urinary tract infection (uti) characterized by abdominal pain; unrelated to dialysis/product.With respect to the reported peritonitis, it was stated that on(b)(6) 2024 the patient was seen in the (b)(6) clinic with symptoms of abdominal pain.The patient had a pd culture obtained (the same day) which grew the bacteria corynebacterium species.The patient was initiated on intra-peritoneal (ip) antibiotic therapy with vancomycin (per clinic protocol) on an outpatient basis.The patient recovered from the peritonitis event and continued pd with the same cycler.The nurse stated the patient did not have any fluid leaks or any issues with fresenius products in relation to the event.The nurse provided that the patient¿s daughter assists with pd therapy due to the patient having pre-existing dementia.It was stated the caregiver has very long fingernails and that hand hygiene was a concern.Therefore, the nurse stated the peritonitis was due to a breach in aseptic technique during the pd exchange.

• 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: 19177320
• MDR Text Key: 341000891
• Report Number: 3023981687-2024-00105
• 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: 04/10/2024
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 04/24/2024
• Date Manufacturer Received: 04/10/2024
• 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: 77 YR
• Patient Sex: Female