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 Myocardial Infarction (1969)

Event Date 01/18/2024

Event Type  Death  

Event Description

On 22/jan/2024, a patient contact reported to fresenius customer service this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy utilizing the liberty select cycler expired while connected to his cycler.There was no specific allegation this event was due to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Upon follow up with the patient¿s pdrn, it was reported this patient expired at home on (b)(6) 2024 due to a myocardial infarction (mi).It was unknown whether the patient was connected to his liberty select cycler at the time of the mi or his death; however, the mi more than likely coincided with a ccpd treatment as he passed during the night.This was further supported by the initial statement from the patient contact.The patient¿s mi was attributed to a significant history of cardiac disease including previous mi¿s.It was believed emergency services were activated but it was reported by the patient contact to the outpatient clinic that he was pronounced deceased in his home.It was confirmed the patient¿s mi leading to his death was unrelated to pd therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).

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 mi, leading to his death.The cause of this patient¿s adverse event can be attributed to a significant history of cardiac disease as reported by a medical professional.It is well known the esrd population continues to have significantly higher mortality and fewer expected years of life when compared to the general population, particularly in the environment of cardiovascular disease.Therefore, the liberty select cycler can be excluded as a root cause or contributor to this patient¿s adverse event.Based on the required information, there is no specific allegation or objective evidence indicating a fresenius device(s) or product(s) deficiency or malfunction, caused or contributed to the patient¿s adverse events.

Event Description

On (b)(6) 2024, a patient contact reported to fresenius customer service this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy utilizing the liberty select cycler expired while connected to his cycler.There was no specific allegation this event was due to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Upon follow up with the patient¿s pdrn, it was reported this patient expired at home on (b)(6) 2024 due to a myocardial infarction (mi).It was unknown whether the patient was connected to his liberty select cycler at the time of the mi or his death; however, the mi more than likely coincided with a ccpd treatment as he passed during the night.This was further supported by the initial statement from the patient contact.The patient¿s mi was attributed to a significant history of cardiac disease including previous mi¿s.It was believed emergency services were activated but it was reported by the patient contact to the outpatient clinic that he was pronounced deceased in his home.It was confirmed the patient¿s mi leading to his death was unrelated to pd therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).

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: 18585616
• MDR Text Key: 333771996
• Report Number: 0002937457-2024-00152
• Device Sequence Number: 1
• Product Code: FKX
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Device Lot Number: LC110918
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2019
• 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: LIBERTY CYCLER SET; LIBERTY CYCLER SET; PD SOLUTION; PD SOLUTION
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 114 KG