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 Encephalopathy (1833); Uremia (2188); Confusion/ Disorientation (2553)

Event Date 02/27/2024

Event Type  Injury  

Event Description

A peritoneal dialysis (pd) patient mentioned being at the hospital.In a follow-up, the patient¿s pd registered nurse (pdrn) reported the patient¿s brother stopped by to visit on (b)(6) 2024 and found the patient confused and disoriented.The patient was transported to the hospital via emergency medical services, and testing (specifics unavailable) revealed the patient was suffering from uremic encephalopathy after being unable to perform pd for approximately 48-hours.The patient reported having difficulty with his liberty select cycler (nurse confirmed, specifics unknown) and being unable to perform manual therapy (rationale not provided).As a result, the patient underwent the surgical placement of a hemodialysis (hd) catheter (not a fresenius product) and was transitioned to hd for rrt.The patient¿s pd catheter (not a fresenius product) currently remains in place; however, it will likely be removed this week.The patient has recovered but remains hospitalized as of (b)(6) 2024 and is not expected to be discharged for several weeks.The patient was transferred from the acute hospital to a rehabilitation hospital on (b)(6) 2024 for physical/occupational therapy.The pdrn stated she has not performed a home visit, nor has the liberty select cycler been returned to the manufacture.

Manufacturer Narrative

Clinical review: a temporal relationship exists between the patient¿s lack of ccpd therapy, the reported liberty select cycler malfunction, and the serious adverse events of uremic encephalopathy, characterized by an altered mental status, confusion, and disorientation, which required hospitalization and the transition of modality from ccpd to hd.Symptoms of uremic encephalopathy can range from mild symptoms such as confusion and lethargy, to more severe symptoms such as hallucinations, seizures, or coma.These cognitive symptoms are known to improve with dialysis and may reverse the symptoms of uremic encephalopathy.Of note: there is a level of non-compliance within the serious adverse events.The patient could have reported the malfunction to the pdrn prior to missing 2 scheduled ccpd treatments.The patient also had the ability/supplies to perform manual peritoneal dialysis but did not.The liberty select cycler cannot be excluded from having a role in the patient¿s serious adverse events.Given the allegation of malfunction made by the patient, the affirmation of the malfunction by the pdrn, and no manufacturer evaluation of the suspect device, this clinical investigation cannot disassociate the liberty select cycler from having indirectly caused the serious adverse events.Plant investigation: no parts were returned to the manufacturer for physical evaluation.A records review was performed on the 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.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 cannot be reached without a physical examination of the device.

• 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: 18908093
• MDR Text Key: 337730461
• Report Number: 0002937457-2024-00438
• 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: 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: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2021
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 90 KG