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 Problems Cardiac Arrest (1762); Hypervolemia (2664); Heart Failure/Congestive Heart Failure (4446)

Event Date 02/20/2023

Event Type  Death  

Manufacturer Narrative

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 cardiac arrest leading to their death.The cause of this patient¿s cardiac arrest can be attributed to a significant cardiac disease history 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

A user facility peritoneal dialysis registered nurse (pdrn) manager reported to customer service that a patient had passed away on the machine.It was reported that the patient was fluid overloaded and had a weak heart.Upon follow up, the pdrn stated the patient expired at home on (b)(6) 2023 due to a cardiac arrest attributed to a significant cardiac disease history.The pdrn affirmed the patient was connected to the liberty select cycler when they were found unresponsive at home by family.The pdrn reported emergency services were not activated and the patient was pronounced deceased in their home.The pdrn stated the patient was fluid overloaded the last time they saw them in the outpatient clinic (exact date unknown, prior to their death) due to an exacerbation of congestive heart failure.The pdrn reported the patient¿s fluid overload did not occur during a pd treatment and it was not caused by a deficiency or malfunction of any fresenius product(s), device(s) or drug(s).Additionally, the pdrn confirmed the patient¿s cardiac arrest leading to their death was unrelated to pd therapy and not due to a deficiency or malfunction of any fresenius product(s), device(s) or drug(s).Additional patient information was unavailable as the patient was removed from the clinic census.

Event Description

A user facility peritoneal dialysis registered nurse (pdrn) manager reported to customer service that a patient had passed away on the machine.It was reported that the patient was fluid overloaded and had a weak heart.Upon follow up, the pdrn stated the patient expired at home on (b)(6) 2023 due to a cardiac arrest attributed to a significant cardiac disease history.The pdrn affirmed the patient was connected to the liberty select cycler when they were found unresponsive at home by family.The pdrn reported emergency services were not activated and the patient was pronounced deceased in their home.The pdrn stated the patient was fluid overloaded the last time they saw them in the outpatient clinic (exact date unknown, prior to their death) due to an exacerbation of congestive heart failure.The pdrn reported the patient¿s fluid overload did not occur during a pd treatment and it was not caused by a deficiency or malfunction of any fresenius product(s), device(s) or drug(s).Additionally, the pdrn confirmed the patient¿s cardiac arrest leading to their death was unrelated to pd therapy and not due to a deficiency or malfunction of any fresenius product(s), device(s) or drug(s).Additional patient information was unavailable as the patient was removed from the clinic census.

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 user facility peritoneal dialysis registered nurse (pdrn) manager reported to customer service that a patient had passed away on the machine.It was reported that the patient was fluid overloaded and had a weak heart.Upon follow up, the pdrn stated the patient expired at home on (b)(6) 2023 due to a cardiac arrest attributed to a significant cardiac disease history.The pdrn affirmed the patient was connected to the liberty select cycler when they were found unresponsive at home by family.The pdrn reported emergency services were not activated and the patient was pronounced deceased in their home.The pdrn stated the patient was fluid overloaded the last time they saw them in the outpatient clinic (exact date unknown, prior to their death) due to an exacerbation of congestive heart failure.The pdrn reported the patient¿s fluid overload did not occur during a pd treatment and it was not caused by a deficiency or malfunction of any fresenius product(s), device(s) or drug(s).Additionally, the pdrn confirmed the patient¿s cardiac arrest leading to their death was unrelated to pd therapy and not due to a deficiency or malfunction of any fresenius product(s), device(s) or drug(s).Additional patient information was unavailable as the patient was removed from the clinic census.

Manufacturer Narrative

Additional information: d9, 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 was performed and completed.The cycler weighed fill volume values were within tolerance for a liberty cycler.The cycler underwent and passed a system air leak test and a valve actuation test.There were no visual discrepancies encountered during the internal inspection.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, 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.

• 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: 16491529
• MDR Text Key: 310769516
• Report Number: 0002937457-2023-00331
• 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,Followup
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 02/22/2023
• Initial Date FDA Received: 03/06/2023
• Supplement Dates Manufacturer Received: 03/13/2023; 04/18/2023
• Supplement Dates FDA Received: 03/20/2023; 04/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2020
• 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: 86 YR
• Patient Sex: Male