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

Catalog Number RTLR180343

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Hypervolemia (2664); Pericarditis (4448)

Event Date 07/17/2023

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: there is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue.

Event Description

It was reported that this male peritoneal dialysis (pd) patient had been hospitalized on (b)(6) 2023 due to inadequate dialysis at home.During an attempted follow-up call to the clinic, the dietician stated the patient was transitioning to in-center hemodialysis (hd).Additional follow-up with the clinic manager documented that the patient was admitted to the hospital on (b)(6) 2023 with a diagnosis of uremic pericarditis.The patient had signs of fluid retention upon hospital admission.During the hospitalization, the patient underwent a pericardiocentesis to remove the fluid from the pericardium.Prior to the hospitalization, the patient had encountered complications with pd therapy.The patient had no residual renal function and initially an adequacy test showed pd therapy was not sufficient.The patient¿s pd prescription had been changed to attempt to correct this.It was eventually discovered that the patient had a pleuroperitoneal leak.Due to this finding and the fluid buildup around the pericardium, it was decided that the patient required transition to hd.A central venous catheter (cvc) was placed, and the patient¿s pd catheter was pulled.The patient was discharged on (b)(6) 2023 and was initiated on in-center hd.The patient¿s hospitalization and fluid retention are unrelated to the liberty select cycler or any fresenius product(s).The patient¿s pleuroperitoneal leak, an anatomic defect of the patient, is the cause of the uremic pericarditis, hospitalization, and transition to hd.The cause of pd fluid leaks is considered to be mainly due to congenital or acquired diaphragmatic defects in the patient.There are multiple predisposing mechanisms for pleuroperitoneal leaks including diaphragmatic muscular hypotonia, congenital diaphragmatic defects, pleuroperitoneal pressure gradients, and lymphatic drainage disorders.In cases of pleuroperitoneal leak, it is the physiology of the patient and not the device that is the cause of the adverse event.There is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue.

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.Clinical investigation: there is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue.

Event Description

It was reported that this male peritoneal dialysis (pd) patient had been hospitalized on (b)(6) 2023 due to inadequate dialysis at home.During an attempted follow-up call to the clinic, the dietician stated the patient was transitioning to in-center hemodialysis (hd).Additional follow-up with the clinic manager documented that the patient was admitted to the hospital on (b)(6) 2023 with a diagnosis of uremic pericarditis.The patient had signs of fluid retention upon hospital admission.During the hospitalization, the patient underwent a pericardiocentesis to remove the fluid from the pericardium.Prior to the hospitalization, the patient had encountered complications with pd therapy.The patient had no residual renal function and initially an adequacy test showed pd therapy was not sufficient.The patient¿s pd prescription had been changed to attempt to correct this.It was eventually discovered that the patient had a pleuroperitoneal leak.Due to this finding and the fluid buildup around the pericardium, it was decided that the patient required transition to hd.A central venous catheter (cvc) was placed, and the patient¿s pd catheter was pulled.The patient was discharged on (b)(6) 2023 and was initiated on in-center hd.The patient¿s hospitalization and fluid retention are unrelated to the liberty select cycler or any fresenius product(s).The patient¿s pleuroperitoneal leak, an anatomic defect of the patient, is the cause of the uremic pericarditis, hospitalization, and transition to hd.The cause of pd fluid leaks is considered to be mainly due to congenital or acquired diaphragmatic defects in the patient.There are multiple predisposing mechanisms for pleuroperitoneal leaks including diaphragmatic muscular hypotonia, congenital diaphragmatic defects, pleuroperitoneal pressure gradients, and lymphatic drainage disorders.In cases of pleuroperitoneal leak, it is the physiology of the patient and not the device that is the cause of the adverse event.There is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue.

• 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: 17499138
• MDR Text Key: 320792398
• Report Number: 0002937457-2023-01174
• 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: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 19 YR
• Patient Sex: Male