MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180343

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

Patient Problems Fatigue (1849); Vomiting (2144); Uremia (2188); Confusion/ Disorientation (2553); Hypervolemia (2664); Swelling/ Edema (4577)

Event Date 12/21/2023

Event Type  Injury  

Manufacturer Narrative

Clinical review: a temporal relationship exists between pd therapy with report of slow drains on the liberty select cycler and the patient¿s subsequent hospitalization for fluid volume overload and uremia.Fluid volume overload is a common complication in patients with end stage renal disease (esrd) on dialysis.It was reported that the patient had multifactorial causes for this event including a report of patient non-compliance, loss of residual renal function and new comorbid condition of congestive heart failure.Based on the information available, there is no objective evidence that a liberty select cycler malfunction or product deficiency caused this adverse event.However, the fresenius cycler was replaced as a precaution to rule out malfunction.Manufacturer product analysis is not available at the time this clinical investigation was completed and therefore it is unknown what was causing the slow drain alarms.Therefore, the device cannot be completed excluded as a possible causal factor in this event.However, the patient¿s noncompliance, loss of residual renal functions and comorbid conditions of congestive heart failure are very likely contributing factors for the patient¿s fluid volume overload and uremia event.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A patient¿s peritoneal dialysis (pd) nurse reported that the patient was experiencing symptoms of weakness, cough, edema in feet, confusion, nausea and vomiting.As a result, on (b)(6) 2023, the patient was admitted to the hospital and diagnosed with fluid volume overload and uremia.While hospitalized, the patient had a hemodialysis catheter placed and received with hemodialysis for renal replacement needs (details unknown).Subsequently, on (b)(6) 2023, the patient left the hospital against medical advice (ama).Per the nurse, the patient completed pd treatments manually after hospitalization and the nurse confirmed the patient received a replacement cycler on (b)(6) 2023.Additionally, the patient received a new iq drive and updated pd prescription on (b)(6) 2023 during a follow-up visit at the outpatient pd clinic.The nurse stated the patient is resuming pd treatment with the replacement cycler and new iq drive/prescription.The pd nurse indicated that the cause of the patient¿s hospitalization (for fluid volume overload and uremia) was multifactorial in nature.It was reported that the patient¿s residual renal function declined since (b)(6) 2023 and ceased in (b)(6) 2023.Per the nurse, the patient was not meeting dialysis adequacy goals and was not having adequate ultrafiltration.Additionally, the patient was newly diagnosed with congestive heart failure in the setting of the further loss of kidney function.Furthermore, the nurse confirmed that the patient may not have been completing his pd treatments as order as the pd treatment data is sporadic.It was reported that the patient experienced some slow flow/ drain issues during pd treatments on the cycler (dates unknown).The nurse stated it is unknown what exactly was causing the drain issues.However, the nurse indicated it is unknown if the patient was performing his pd treatments properly and stated that he drain issues may be related to the patient draining into a sink.Regardless, a request for a replacement cycler was made as a precaution (per the patient¿s physician) as the patient was hospitalized.Per the nurse, the patient will have a home visit for re-education on performing his dialysis treatments properly as needed.

• Brand Name: LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 18472067
• MDR Text Key: 332375022
• Report Number: 0002937457-2024-00038
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/19/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID.; LIBERTY CYCLER SET.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male