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

Model Number 180343

Device Problem Overfill (2404)

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

Event Date 05/19/2023

Event Type  Injury  

Event Description

A peritoneal dialysis (pd) nurse reported a patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized due to fluid overload.During follow-up, the patient¿s pdrn confirmed the patient presented to the emergency room on (b)(6) 2023 with shortness of breath (dyspnea) and generalized edema.The patient reportedly underwent several x-rays, which determined the patient was suffering from fluid overload.The patient¿s pd catheter (not a fresenius product) placement was evaluated and was found to be properly seated in the peritoneum.The patient was admitted, and a temporary hemodialysis (hd) catheter (not a fresenius product) was surgically placed.The patient was transitioned to hd therapy for more rapid ultrafiltration to address the patient fluid overload.The patient successfully underwent four hd treatments on (b)(6) 2023 through on (b)(6) 2023 and was discharged home following the final treatment.The patient is currently undergoing ¿backup¿ outpatient hd therapy until a peritoneal equilibration test (pet) can be completed to assess the patient¿s peritoneal membrane transport function.The pdrn reported the patient¿s dyspnea resolved while hospitalized and she has recovered from the events.The pdrn reported the patient¿s serious adverse events were unrelated to the patient¿s utilization of any fresenius device(s) and/or product(s), regardless of the patient¿s allegation.A discharge summary was unavailable, however the pdrn attributed causality to membrane failure despite the pending pet.

Manufacturer Narrative

Clinical review: 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 temporary transition of modality to hd.Despite the patient¿s allegation of cycler malfunction, the patient¿s pdrn reported causality was due to the patient experiencing peritoneal membrane failure.Per the pdrn, the serious adverse events were unrelated to the patient¿s utilization of any fresenius device(s) and/or product(s).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 events.There is no clinical allegation or objective evidence indicating a fresenius product(s) and/or device(s) caused or contributed to the serious adverse events.Furthermore, there was no report a fresenius device(s) and/or product(s) failed to meet manufacturer specifications.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

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

A peritoneal dialysis (pd) nurse reported a patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized due to fluid overload.During follow-up, the patient¿s pdrn confirmed the patient presented to the emergency room on (b)(6) 2023 with shortness of breath (dyspnea) and generalized edema.The patient reportedly underwent several x-rays, which determined the patient was suffering from fluid overload.The patient¿s pd catheter (not a fresenius product) placement was evaluated and was found to be properly seated in the peritoneum.The patient was admitted, and a temporary hemodialysis (hd) catheter (not a fresenius product) was surgically placed.The patient was transitioned to hd therapy for more rapid ultrafiltration to address the patient fluid overload.The patient successfully underwent four hd treatments on (b)(6) 2023 through (b)(6) 2023 and was discharged home following the final treatment.The patient is currently undergoing ¿backup¿ outpatient hd therapy until a peritoneal equilibration test (pet) can be completed to assess the patient¿s peritoneal membrane transport function.The pdrn reported the patient¿s dyspnea resolved while hospitalized and she has recovered from the events.The pdrn reported the patient¿s serious adverse events were unrelated to the patient¿s utilization of any fresenius device(s) and/or product(s), regardless of the patient¿s allegation.A discharge summary was unavailable, however the pdrn attributed causality to membrane failure despite the pending pet.

• 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: 17102525
• MDR Text Key: 316946691
• Report Number: 0002937457-2023-00825
• 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: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2023
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2017
• 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; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 63 KG