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 Problem Myocardial Infarction (1969)

Event Date 05/27/2023

Event Type  Death  

Event Description

On (b)(6) 2023, a patient contact reported to fresenius customer service this 79-year-old male 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 pd registered nurse, it was reported this patient expired at home on (b)(6) 2023 due to a myocardial infarction (mi) attributed to cardiac comorbidities.It was affirmed the patient was connected to his cycler at the time of his mi leading to his death.The events surrounding the patient¿s passing were unknown, but it was reported he was found pulseless by family at home, and he was not transported to the hospital.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

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical review: a temporal relationship exists between ccpd therapy utilizing the liberty select cycler and the patient¿s death.The cause of the patient¿s death can be attributed to an mi due to cardiac comorbidities 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 cardiac disease.Therefore, the liberty select cycler can be excluded as a root cause or contributor to this patient¿s adverse event.Based on the available 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.

Manufacturer Narrative

Additional information provided in d9 and h3.Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed on the cycler with no physical damage noted.An as received simulated treatment with reduced dwell times was performed and completed without any failures or problems.The cycler weighed fill volume values were within tolerance for a liberty cycler.The cycler underwent and passed a system air leak test, valve actuation test, and teach pump test.There were no visual discrepancies encountered during the internal inspection.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

On 30/may/2023, a patient contact reported to fresenius customer service this 79-year-old male 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 pd registered nurse, it was reported this patient expired at home on 27/may/2023 due to a myocardial infarction (mi) attributed to cardiac comorbidities.It was affirmed the patient was connected to his cycler at the time of his mi leading to his death.The events surrounding the patient¿s passing were unknown, but it was reported he was found pulseless by family at home, and he was not transported to the hospital.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.

Event Description

On 30/may/2023, a patient contact reported to fresenius customer service this 79-year-old male 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 pd registered nurse, it was reported this patient expired at home on (b)(6) 2023 due to a myocardial infarction (mi) attributed to cardiac comorbidities.It was affirmed the patient was connected to his cycler at the time of his mi leading to his death.The events surrounding the patient¿s passing were unknown, but it was reported he was found pulseless by family at home, and he was not transported to the hospital.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).

• 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: 17078251
• MDR Text Key: 316692477
• Report Number: 0002937457-2023-00810
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• 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
• Device Age: MO
• Date Manufacturer Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2020
• 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; DELFLEX PD FLUID; LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; LIBERTY CYCLER SET
• Patient Outcome(s): Death
• Patient Age: 79 YR
• Patient Sex: Male