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 12/07/2023

Event Type  Injury  

Event Description

On 11/dec/2023 this peritoneal dialysis (pd) patient contacted fresenius technical support stating she has been experiencing drain and fill issues during treatments on the liberty select cycler.The patient was in the hospital at the time of the call pending discharge.The doctor would not discharge the patient unless there was a working liberty select cycler at home.The patient was hospitalized for breathing and other issues not directly related to the cycler.The patient previously had the pd catheter replaced due to drain and fill issues.The patient had not contacted technical support for troubleshooting these issues.Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The pdrn stated the patient was having issues breathing and was admitted to the hospital on (b)(6) 2023.The patient was diagnosed with fluid volume overload (fvo).The patient was discharged on (b)(6) 2023.No information related to the patient¿s course of treatment during the hospitalization was provided.The patient is completing manual exchanges while awaiting a replacement cycler.The pdrn stated the patient was experiencing issues with draining during treatments while utilizing the liberty select cycler prior to the hospitalization.The pdrn alleges that this is the cause of the patient¿s fvo.No further information was provided.

Manufacturer Narrative

Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: there is a temporal relationship between peritoneal dialysis utilizing the liberty select cycler and the patient event of fluid volume overload with hospitalization.Although the patient¿s pdrn alleges the cycler drain issues caused the patient¿s fvo, there is no documentation in the complaint file to show a malfunction or deficiency with the liberty select cycler.The patient stated they were having both drain and fill issues.The patient never called technical support to report any problems encountered during treatment.There is no record of any reported calls from the patient reporting any drain issues with the liberty select cycler.No live troubleshooting has been conducted.The pdrn did not confirm if any clinical assessment of the patient has been completed to determine if there is an issue with the pd catheter or a positional problem.The patient had a recent pd catheter replacement due to experiencing the same issues with draining and filling.The patient¿s cycler was replaced due to the demand of the physician and not due to any documented malfunction.Based on the available information and no records of any calls for cycler issues or clinical assessment of the patient, it cannot be concluded if the liberty select cycler caused or contributed to the patient¿s fvo and hospitalization.

Manufacturer Narrative

Additional information: d9, h3 plant investigation: the actual device was returned to the manufacturer for physical evaluation.An exterior visual inspection of the returned cycler showed no sign of physical damage.There were visual indications of dried fluid within the cassette compartment.There was no visual indication of particulates within the cassette area.There were no burrs or sharp edges in cassette area that may have punctured a cassette membrane.A (as-received with reduced dwell) simulated treatment was performed and completed.The cycler weighed fill volume values were within tolerance for a liberty cycler.The system air leak test passed.The valve actuation test passed.The teach pump test passed.The patient sensor check passed.There were visual indications of dried fluid on the bottom cover underneath the pump assembly.The cause of the observed dried fluid could not be determined.There were no discrepancies encountered with the mushroom heads.The device history record did not reveal any issues or problems related to the reported symptom code(s).A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.There were no malfunctions found during testing that could have caused or contributed to the reported event.The cycler performed as designed and an associated cause could not be determined.

Event Description

On (b)(6) 2023 this peritoneal dialysis (pd) patient contacted fresenius technical support stating she has been experiencing drain and fill issues during treatments on the liberty select cycler.The patient was in the hospital at the time of the call pending discharge.The doctor would not discharge the patient unless there was a working liberty select cycler at home.The patient was hospitalized for breathing and other issues not directly related to the cycler.The patient previously had the pd catheter replaced due to drain and fill issues.The patient had not contacted technical support for troubleshooting these issues.Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The pdrn stated the patient was having issues breathing and was admitted to the hospital on (b)(6) 2023.The patient was diagnosed with fluid volume overload (fvo).The patient was discharged on (b)(6) 2023.No information related to the patient¿s course of treatment during the hospitalization was provided.The patient is completing manual exchanges while awaiting a replacement cycler.The pdrn stated the patient was experiencing issues with draining during treatments while utilizing the liberty select cycler prior to the hospitalization.The pdrn alleges that this is the cause of the patient¿s fvo.

• 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: 18336074
• MDR Text Key: 330665584
• Report Number: 0002937457-2023-01889
• 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,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• 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?: Device Returned to Manufacturer
• Device Age: MO
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2012
• 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: LIBERTY CYCLER SET; LIBERTY CYCLER SET; PD SOLUTION; PD SOLUTION
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female