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 Myocardial Infarction (1969); Peritonitis (2252)

Event Date 01/01/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized.During intake, the pd registered nurse (pdrn) reported the patient contracted peritonitis while hospitalized and is no longer able to perform pd therapy.A written response from the patient¿s pdrn revealed the patient was hospitalized (admission date not provided, >30-day hospitalization) due to a st elevation myocardial infarction (stemi).It was reported the patient developed peritonitis while admitted and required transition to alternate form of rrt (modality type not provided).As of (b)(6) 2023, the patient remained hospitalized and is recovering from the serious adverse events.Additional information (e.G., hospital records, medication records, treatment records) was requested, however the patient¿s medical record was closed.The patient was discharged from the outpatient home program after being hospitalized for >30 days.Additional information was requested however the request could not be fulfilled as the patient¿s electronic medical record was closed.

• 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: 17625134
• MDR Text Key: 321971987
• Report Number: 3023981687-2023-00178
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 050-87216
• 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: 08/25/2023
• Distributor Facility Aware Date: 08/08/2023
• Device Age: MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/25/2023
• Date Manufacturer Received: 08/08/2023
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 62 KG