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 Dyspnea (1816); Hypervolemia (2664)

Event Date 09/28/2023

Event Type  Injury  

Manufacturer Narrative

Clinical review: a temporal relationship exists between pd therapy with the liberty select cycler (with report of pressure leak alarm) and the patient¿s subsequent hospitalization for fluid volume overload.Fluid volume overload is a common complication in patients with end stage renal disease (esrd) on dialysis.It was reported by the patient¿s pd nurse, that the patient was not using the appropriate strength pd solution for several pd treatments prior to hospitalization which impacted the patient¿s ability to remove fluid.Additionally, when the fresenius cycler was being replaced for the reported alarm, the patient was non-compliant with performing manual pd exchanges as medically advised.Based on the reported information, the liberty select cycler did not cause direct harm to the patient but was a contributing factor in this event.However, the patient¿s hospitalization for fluid volume overload can largely be attributed to patient error and noncompliance to manual pd exchanges as medically advised, as reported by the patient¿s pd nurse.Plant investigation: no parts were returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Event Description

A peritoneal dialysis (pd) patient reported being hospitalized for fluid volume overload characterized by shortness of breath.The patient stated not being able to complete pd treatment for 3 days.The patient received a replacement cycler due to a pressure leak alarm.In additional follow up, the patient¿s pd nurse confirmed that the patient did not experience any adverse effects from the pressure leak alarm.However, the patient was hospitalized for fluid volume overload on (b)(6) 2023 (after missing pd treatment).During hospitalization, the patient received pd therapy (details unknown) and the patient was subsequently discharged home on (b)(6) 2023.Per the nurse, the patient¿s fluid overload was due to many factors.It was indicated the patient was using 4.25% strength delflex for multiple treatments in september when the patient should have been utilizing 1.5% or 2.5% strength delflex solution (patient error).Additionally, the patient did not perform manual pd exchanges when medically advised.

• 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: 17958743
• MDR Text Key: 325965108
• Report Number: 0002937457-2023-01579
• 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: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Device Age: MO
• Initial Date Manufacturer Received: 09/29/2023
• Initial Date FDA Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2021
• 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 Age: 75 YR
• Patient Sex: Male