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 Chest Pain (1776)

Event Date 07/30/2022

Event Type  Death  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: patients with end stage renal disease exhibit a markedly elevated risk for cardiovascular events.Cardiovascular disease is the leading cause of death in this high-risk population.There is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.

Event Description

On (b)(6) 2022 it was reported that this 51-year-old female peritoneal dialysis (pd) patient had passed away.In a call to the pd clinic, the peritoneal dialysis registered nurse (pdrn) reported the patient had gone to the emergency room (er) and passed away while in the er.The death was due to a cardiac event.Additional information was obtained through the pdrn.The patient was experiencing chest pain on (b)(6) 2022 and went to the er.It is unknown if the patient was in treatment at the time of the event.There is no information indicating the patient was connected to the liberty select cycler.The patient passed away in the er due to cardiopulmonary arrest.The patient had a recent myocardial infarction (date not provided).The patient has significant cardiac comorbidities including chronic diastolic congestive heart failure and atherosclerotic heart disease.

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 02/aug/2022 it was reported that this 51-year-old female peritoneal dialysis (pd) patient had passed away.In a call to the pd clinic, the peritoneal dialysis registered nurse (pdrn) reported the patient had gone to the emergency room (er) and passed away while in the er.The death was due to a cardiac event.Additional information was obtained through the pdrn.The patient was experiencing chest pain on (b)(6) 2022 and went to the er.It is unknown if the patient was in treatment at the time of the event.There is no information indicating the patient was connected to the liberty select cycler.The patient passed away in the er due to cardiopulmonary arrest.The patient had a recent myocardial infarction (date not provided).The patient has significant cardiac comorbidities including chronic diastolic congestive heart failure and atherosclerotic heart disease.

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 without failures.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.An investigation of the cycler mushroom heads verified that the surface conditions and alignments were within specification.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, the leak event is confirmed due to the presence dried fluid within the device, which is indicative of fluid contact.There were no malfunctions found during testing 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 02/aug/2022 it was reported that this 51-year-old female peritoneal dialysis (pd) patient had passed away.In a call to the pd clinic, the peritoneal dialysis registered nurse (pdrn) reported the patient had gone to the emergency room (er) and passed away while in the er.The death was due to a cardiac event.Additional information was obtained through the pdrn.The patient was experiencing chest pain on (b)(6) 2022 and went to the er.It is unknown if the patient was in treatment at the time of the event.There is no information indicating the patient was connected to the liberty select cycler.The patient passed away in the er due to cardiopulmonary arrest.The patient had a recent myocardial infarction (date not provided).The patient has significant cardiac comorbidities including chronic diastolic congestive heart failure and atherosclerotic heart disease.

Event Description

On (b)(6)2022 it was reported that this 51-year-old female peritoneal dialysis (pd) patient had passed away.In a call to the pd clinic, the peritoneal dialysis registered nurse (pdrn) reported the patient had gone to the emergency room (er) and passed away while in the er.The death was due to a cardiac event.Additional information was obtained through the pdrn.The patient was experiencing chest pain on (b)(6)2022 and went to the er.It is unknown if the patient was in treatment at the time of the event.There is no information indicating the patient was connected to the liberty select cycler.The patient passed away in the er due to cardiopulmonary arrest.The patient had a recent myocardial infarction (date not provided).The patient has significant cardiac comorbidities including chronic diastolic congestive heart failure and atherosclerotic heart disease.

Manufacturer Narrative

Correction: h10 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 without failures.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.An investigation of the cycler mushroom heads verified that the surface conditions and alignments were within specification.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.There were no malfunctions found during testing 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: 15260219
• MDR Text Key: 298237616
• Report Number: 0002937457-2022-01386
• 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,Followup
• Report Date: 10/03/2022

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
• Device Age: MO
• Initial Date Manufacturer Received: 08/02/2022
• Initial Date FDA Received: 08/19/2022
• Supplement Dates Manufacturer Received: 08/29/2022; 09/15/2022; 09/30/2022
• Supplement Dates FDA Received: 08/30/2022; 09/28/2022; 10/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2020
• 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; DELFLEX PD FLUID; LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; LIBERTY CYCLER SET
• Patient Outcome(s): Death
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 86 KG