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 Fatigue (1849); Pain (1994); Peritonitis (2252)

Event Date 02/21/2024

Event Type  Injury  

Event Description

On 6/mar/2024, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a liberty select cycler and liberty cycler set for renal replacement therapy (rrt) was hospitalized on (b)(6) 2024 due to suspected peritonitis.No additional information was provided during intake.Follow-up with the patient¿s pd registered nurse (pdrn) confirmed the patient was admitted on (b)(6) 2024 with complaints of leg pain and weakness.Further testing revealed the patient was experiencing ¿significant¿ hyperkalemia (value not provided), however it is unclear what, if any, medical intervention was provided.Per the patient¿s nephrologist, causality was attributed to peritoneal membrane failure.A peritoneal effluent fluid culture and cell count were collected on admission and despite the results being negative, the patient¿s peritoneal effluent fluid was cloudy.Therefore, the patient was initially treated with vancomycin and ceftazidime, however due to persistently cloudy peritoneal effluent fluid the patient¿s ceftazidime was discontinued and replaced with meropenem (route, frequency, dose not provided).The patient was diagnosed with suspected peritonitis and the antibiotic course will continue through (b)(6) 2024.As of (b)(6) 2024, the patient remained hospitalized and was scheduled to be discharged in the next few days.The patient has recovered from the serious adverse events and will resume utilizing the same liberty select cycler following discharge.Per the pdrn, the serious adverse events were not caused by a fresenius device(s) and/or product(s) malfunction or deficiency.

• 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: 18904346
• MDR Text Key: 337671205
• Report Number: 3023981687-2024-00074
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/14/2024
• Distributor Facility Aware Date: 03/06/2024
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 03/14/2024
• Date Manufacturer Received: 03/06/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIBERTY SELECT CYCLER; PD SOLUTION
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 113 KG