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 03/14/2024

Event Type  Injury  

Event Description

On 14/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 for renal replacement therapy (rrt) was hospitalized for fluid overload due to the patient skipping treatment.During follow-up, the patient¿s pd registered nurse (pdrn) confirmed the patient had skipped three consecutive treatments and became short of breath while at home on (b)(6) 2024.The patient attempted to perform ccpd therapy to address her shortness of breath.However, it was reported the patient did not perform the treatment correctly (specifics not provided) and her symptoms became worse.The patient was transported via emergency medical services (ems) to the hospital where radiological testing revealed the patient was suffering from fluid overload.Given the patient¿s advanced age and chronic non-compliance, the nephrologist ordered the patient be transitioned to incenter hemodialysis (hd) for the foreseeable future.While admitted, the patient received a tunneled hd catheter (not a fresenius product), while also having her pd catheter (not a fresenius product) surgically removed.The patient began undergoing hd therapy without any known issues and was discharged home on (b)(6) 2024.The patient¿s first outpatient hd treatment occurred on (b)(6) 2024 without any reported issues.

Manufacturer Narrative

Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: a temporal relationship exists between ccpd therapy utilizing the liberty select cycler, and the patient¿s serious adverse events of fluid overload, characterized by dyspnea, which warranted hospitalization and the transition to hd therapy, as the patient.The pdrn attributed causality to the patient¿s advanced age and chronic non-compliance with performing ccpd therapy nightly.Per the pdrn, the reported the serious adverse events were unrelated to the patient¿s utilization of any fresenius device(s) and/or product(s).Nonadherence to the prescribed frequency of treatment can lead to electrolyte imbalances, fluid overload, exacerbation of symptoms, and higher mortality.Fluid overload is a common finding among dialysis patients and is frequently multifactorial in its etiology.Based on the information available, the patient¿s liberty select cycler can be disassociated from the serious adverse events.There is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) caused or contributed to the serious adverse events.Furthermore, there was no report that a fresenius device(s) and/or product(s) failed to meet the users¿ expectations or the manufacturers¿ specifications.

Event Description

On (b)(6) 2024, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a liberty select cycler for renal replacement therapy (rrt) was hospitalized for fluid overload due to the patient skipping treatment.During follow-up, the patient¿s pd registered nurse (pdrn) confirmed the patient had skipped three consecutive treatments and became short of breath while at home on (b)(6) 2024.The patient attempted to perform ccpd therapy to address her shortness of breath.However, it was reported the patient did not perform the treatment correctly (specifics not provided) and her symptoms became worse.The patient was transported via emergency medical services (ems) to the hospital where radiological testing revealed the patient was suffering from fluid overload.Given the patient¿s advanced age and chronic non-compliance, the nephrologist ordered the patient be transitioned to incenter hemodialysis (hd) for the foreseeable future.While admitted, the patient received a tunneled hd catheter (not a fresenius product), while also having her pd catheter (not a fresenius product) surgically removed.The patient began undergoing hd therapy without any known issues and was discharged home on (b)(6) 2024.The patient¿s first outpatient hd treatment occurred on 19/mar/2024 without any reported issues.

Manufacturer Narrative

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.

• 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: 18975920
• MDR Text Key: 338550705
• Report Number: 0002937457-2024-00502
• 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: K222318
• 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,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• 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
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2018
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 47 KG