MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Model Number 180343

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Hypervolemia (2664); Swelling/ Edema (4577)

Event Date 05/15/2023

Event Type  Injury  

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

Fresenius became aware of this patient on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was transitioned to ¿back-up¿ hemodialysis (hd) due to fluid overload.During follow-up, the patient¿s pd registered nurse (pdrn) confirmed the patient was transitioned from pd therapy to back-up hd on (b)(6) 2023 due to fluid overload.During a clinic visit on (b)(6) 2023, the patient arrived over their established dry weight (weight unavailable), was mildly dyspneic, and was experiencing bilateral lower extremity edema.The patient was diagnosed with fluid overload and scheduled to undergo an outpatient temporary hd catheter (not a fresenius product) placement on (b)(6) 2023.The patient¿s hd catheter placement surgery was performed without issue, and the patient presented to the outpatient hd clinic on (b)(6) 2023 to begin back-up hd for more rapid ultrafiltration (uf).The pdrn reported the patient had been experiencing negative uf¿s (duration not provided) but did not report them to the pdrn.During further evaluation, it was also discovered the patient was constipated due to bowel medication non-compliance and his furosemide prescription had ¿ran out¿ 3-weeks prior and the patient neglected to obtain a refill.The pdrn stated the fluid overload was caused by the cumulation of these three factors/events.Per the pdrn, the serious adverse events were unrelated to any fresenius product(s) and/or device(s).The pdrn confirmed the patient will resume ccpd on (b)(6) 2023 utilizing the same liberty select cycler despite the patient¿s initial concerns.

Manufacturer Narrative

Additional information provided in d9 and h3.Plant investigation: a visual inspection of the returned cycler exterior showed no sign of physical damage.There were visual indications of dried fluid encountered within the cassette compartment.There was visual indication of particulates around the catch post area and within cassette compartment.There were no burrs or sharp edges in the cassette area that may have punctured a cassette membrane.A post- accelerated stress test (ast) 2 hour 15 min 8500 ml simulated treatment was performed and completed without any failures or problems.Total ultrafiltration (uf) is 88 ml.Function/display test passed.Valve actuation test passed.System air leak test passed.There were visual indications of dried fluid found in between the pump assembly and front panel assembly during internal inspection.There were visual indications of dried fluid within the recess of the bottom cover adjacent to the pump during internal inspection.Mushroom heads check passed.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.Upon completion of the evaluation, there were no malfunctions 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

Fresenius became aware of this patient on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was transitioned to ¿back-up¿ hemodialysis (hd) due to fluid overload.During follow-up, the patient¿s pd registered nurse (pdrn) confirmed the patient was transitioned from pd therapy to back-up hd on (b)(6) 2023 due to fluid overload.During a clinic visit on (b)(6) 2023, the patient arrived over their established dry weight (weight unavailable), was mildly dyspneic, and was experiencing bilateral lower extremity edema.The patient was diagnosed with fluid overload and scheduled to undergo an outpatient temporary hd catheter (not a fresenius product) placement on (b)(6) 2023.The patient¿s hd catheter placement surgery was performed without issue, and the patient presented to the outpatient hd clinic on (b)(6) 2023 to begin back-up hd for more rapid ultrafiltration (uf).The pdrn reported the patient had been experiencing negative uf¿s (duration not provided) but did not report them to the pdrn.During further evaluation, it was also discovered the patient was constipated due to bowel medication non-compliance and his furosemide prescription had ¿ran out¿ 3-weeks prior and the patient neglected to obtain a refill.The pdrn stated the fluid overload was caused by the cumulation of these three factors/events.Per the pdrn, the serious adverse events were unrelated to any fresenius product(s) and/or device(s).The pdrn confirmed the patient will resume ccpd on (b)(6) 2023 utilizing the same liberty select cycler despite the patient¿s initial concerns.

• 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: 17234510
• MDR Text Key: 318175168
• Report Number: 0002937457-2023-00938
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 180343
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2019
• 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: DEFLEX PD FLUID; DEFLEX PD FLUID; LIBERTY CYCLER SET ; LIBERTY CYCLER SET
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 102 KG