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 11/13/2023

Event Type  Death  

Manufacturer Narrative

Clinical review: a temporal relationship exists between ccpd therapy utilizing the liberty select cycler and the patient¿s mi, leading to her death.The cause of this patient¿s death 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.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 registered nurse (pdrn) reported a peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy utilizing a cycler expired due to a heart attack while connected to her cycler.There was no specific allegation this event was due to a deficiency or malfunction of any 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 13/nov/2023 due to a myocardial infarction (mi) attributed to a significant history of cardiac disease.It was affirmed the patient was connected to the cycler at the time of the mi and subsequent death.Emergency services were activated but the patient was pronounced deceased in the home with no hospital transport or lifesaving measures.It was reported the patient had congenital comorbidities and recently lost a spouse, causing deep depression prior to this event.It was confirmed the patient¿s death due to an mi was not due to a deficiency or malfunction of any product(s) or device(s).

Manufacturer Narrative

Additional information: d.9., h.3.Plant investigation: the actual device was returned.A visual inspection of the returned cycler exterior showed that the pump door was cracked next to the door button.There were no visual indication of particulates within the cassette compartment.There were no burrs or sharp edges in cassette area that may have punctured a cassette membrane.A simulated treatment using (as-received) treatment settings with reduced dwell times was performed and completed without failures.No fluid leaks in the test cassette during the treatment test.System air leak test passed.Valve actuation test passed.The internal inspection of the cycler showed that there were visual indications of dried fluid on the bottom cover between the front panel assembly and the pump assembly.The cause of the encountered dried fluid could not be determined.Mushroom head check passed.The device history record did not reveal any issues or problems related to the reported symptom code(s).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

A peritoneal dialysis registered nurse (pdrn) reported a peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy utilizing a cycler expired due to a heart attack while connected to her cycler.There was no specific allegation this event was due to a deficiency or malfunction of any 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) 2023 due to a myocardial infarction (mi) attributed to a significant history of cardiac disease.It was affirmed the patient was connected to the cycler at the time of the mi and subsequent death.Emergency services were activated but the patient was pronounced deceased in the home with no hospital transport or lifesaving measures.It was reported the patient had congenital comorbidities and recently lost a spouse, causing deep depression prior to this event.It was confirmed the patient¿s death due to an mi was not due to a deficiency or malfunction of any product(s) or device(s).

• 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: 18258344
• MDR Text Key: 329624344
• Report Number: 0002937457-2023-01821
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2020
• 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): Death
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 82 KG