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 Problem Hypervolemia (2664)

Event Date 02/16/2024

Event Type  Injury  

Event Description

On (b)(6) 2023, it was reported that this patient on peritoneal dialysis (pd) was hospitalized on (b)(6) 2024.It was alleged the fresenius cycler was not draining the amount the patient was filled with which resulted in the patent being ¿overloaded¿.It was stated the patient would not be discharged from the hospital without a replacement cycler.Treatment data recorded from (b)(6) 2024 revealed that there was no evidence of an overfill or cycler performing as intended.In additional follow up, the patient¿s pd nurse confirmed the patient was hospitalized on (b)(6) 2024 for fluid volume overload, comorbid atrial fibrillation (that was pre-existing) and anemia from chronic kidney disease.The nurse provided that the patient has a long-standing history of non-compliance.It was stated that the patient needed an increase in fill volume as the fill volume (2000ml) was too low for the patient causing inadequate dialysis.However, the patient refused the increasing fill volume.Additionally, the nurse indicated the patient should have been using 4.25% strength pd solution to assist with fluid removal and the patient was using 2.5% strength pd solution.Moreover, it was stated the patient is not always complaint with fluid restrictions and skips their outpatient pd clinic appointments.While hospitalized, the patient required blood transfusion (for the anemia).The patient is also receiving pd treatments (details are unknown).However, the nurse reported that the nephrologist is determining best prescription for patient to meet dialysis adequacy and so there are changes being made to fill volumes, number of exchanges and pd solution strength.Furthermore, the patient had an ongoing respiratory illness that was present prior to hospitalization; unknown if patient had covid.Per the nurse, the emergency room doctor alleged the machine contributed to the fluid overload based on the patient¿s report that the cycler did not drain the patient.However, the nurse stated the patient¿s fluid volume overload is likely due to patient non-compliance with using the correct pd solution strength and refusing to increase fill volume for dialysis is what led to the patient becoming fluid overloaded.The nurse reported the patient¿s cycler was set to 85% drain exit criteria.The nurse confirmed that the cycler was working as intended and did not cause any overfill events and that the machine did not cause the patient¿s fluid overload.

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 pd therapy with the liberty select cycler and the patient¿s subsequent hospitalization for fluid volume overload with pre-existing atrial fibrillation and anemia of chronic kidney disease.It was alleged that the fresenius cycler caused the patient¿s fluid volume overload as it was stated the patient was not drained the amount the patient was filled with.However, review of treatment data reveals the fresenius cycler was likely working as intended and meeting the 85% drain exit criteria set for the patient.Fluid volume overload is a common complication in patients with end stage renal disease (esrd) on dialysis.The patient¿s pd nurse reported that the patient was non-compliant with using the required strength pd solution for fluid removal needs, non-compliant with pd prescription of an increase fill volume and non-compliant with fluid restrictions.It was alleged the fresenius cycler caused the patient¿s fluid volume overload as it was stated the patient was not being drained the amount filled.However, review of treatment data reveals the cycler was working as intended according to 85% drain exit criteria.Based on all the available information, the patient¿s fluid volume overload is likely to be associated with multiple aspects of patient¿s non-compliance.

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.

Event Description

On (b)(6) 2023, it was reported that this patient on peritoneal dialysis (pd) was hospitalized on (b)(6) 2024.It was alleged the fresenius cycler was not draining the amount the patient was filled with which resulted in the patent being ¿overloaded¿.It was stated the patient would not be discharged from the hospital without a replacement cycler.Treatment data recorded from (b)(6) 2024 revealed that there was no evidence of an overfill or cycler performing as intended.In additional follow up, the patient¿s pd nurse confirmed the patient was hospitalized on (b)(6) 2024 for fluid volume overload, comorbid atrial fibrillation (that was pre-existing) and anemia from chronic kidney disease.The nurse provided that the patient has a long-standing history of non-compliance.It was stated that the patient needed an increase in fill volume as the fill volume (2000ml) was too low for the patient causing inadequate dialysis.However, the patient refused the increasing fill volume.Additionally, the nurse indicated the patient should have been using 4.25% strength pd solution to assist with fluid removal and the patient was using 2.5% strength pd solution.Moreover, it was stated the patient is not always complaint with fluid restrictions and skips their outpatient pd clinic appointments.While hospitalized, the patient required blood transfusion (for the anemia).The patient is also receiving pd treatments (details are unknown).However, the nurse reported that the nephrologist is determining best prescription for patient to meet dialysis adequacy and so there are changes being made to fill volumes, number of exchanges and pd solution strength.Furthermore, the patient had an ongoing respiratory illness that was present prior to hospitalization; unknown if patient had covid.Per the nurse, the emergency room doctor alleged the machine contributed to the fluid overload based on the patient¿s report that the cycler did not drain the patient.However, the nurse stated the patient¿s fluid volume overload is likely due to patient non-compliance with using the correct pd solution strength and refusing to increase fill volume for dialysis is what led to the patient becoming fluid overloaded.The nurse reported the patient¿s cycler was set to 85% drain exit criteria.The nurse confirmed that the cycler was working as intended and did not cause any overfill events and that the machine did not cause the patient¿s fluid overload.

• 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: 18846940
• MDR Text Key: 337009256
• Report Number: 0002937457-2024-00394
• 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,Followup
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• 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: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2013
• 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; Life Threatening; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Male