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 Chest Pain (1776)

Event Date 08/17/2023

Event Type  Death  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: there is a temporal relationship between pd therapy utilizing the liberty select cycler and the patient event of chest pains with subsequent death.However, there is no documentation in the complaint file to show a causal relationship between the adverse event and use of the cycler.Additionally, there is no allegation of a device malfunction or deficiency reported for this event.The pdrn stated a review of the patient¿s treatment records was completed and no issues were found.The reported cause of death for the patient was esrd, cardiac arrest, and respiratory failure.It was reported that this patient was diabetic with poor blood sugar control.The patient¿s blood sugars had been high for several days prior to the death.The patient was advised to go to the hospital prior to initiating treatment on the evening before their death.The patient also had a reported history of coronary artery disease and obesity in addition to diabetes.Diabetes mellitus (dm) is a potent cardiovascular risk factor in the general population as well as in those undergoing maintenance dialysis.Poor glycemic control appears to be associated with decreased survival in pd patients.Long-term survival rate of pd patients remains low with cardiovascular disease (cvd) being highly prevalent in patients with eskd.Based on the available information and no allegation or evidence of a malfunction or deficiency, the liberty select cycler can be excluded as the cause of the patient¿s chest pain and death.

Event Description

It was reported that this male peritoneal dialysis (pd) patient experienced chest pain during their treatment on the liberty select cycler.The patient went to the hospital where they subsequently passed away.Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was in treatment in the early morning of(b)(6) 2023 connected to the liberty select cycler.The patient¿s spouse called the pdrn to state the patient was experiencing chest pain.The patient was in fill 4 of 5.The patient had drained 1,700ml of 2,500ml in the previous drain.It was unknown how much of the fill the patient completed prior to the call.The pdrn advised the spouse to call 911.Emergency medical services (ems) arrived and the pdrn assisted ems via phone with disconnecting the patient from the cycler.The patient was alert and talking during this time.The patient remained alert until they were placed in the ambulance, at which time they became unresponsive.The patient was transported to the hospital.The patient was pronounced deceased in the emergency room (er) at 3:40am.The patient¿s death certificate states the cause of death as end stage renal disease (esrd), cardiac arrest, and respiratory failure.The pdrn stated they reviewed the patient¿s treatment record.The pdrn did not see any alarms prior to the event.The pdrn stated that they had called the patient on the evening of (b)(6) 2023, prior to the patient connecting to treatment, as they were attempting to reschedule a kt/v test.They had been trying to reach the patient for several days with no response.The patient¿s treatment had recently been adjusted due to the results of their last kt/v.The patient stated they did not notice any change with the adjustments and did not feel well that evening.The pdrn stated the patient is diabetic and their blood sugars are not controlled.The week before their death, their blood sugar was 1,200 and their records indicated they had been high for the previous six days.During the call the pdrn advised the patient to go to the hospital to be examined.The patient did not go.The pdrn stated the patient has a history of coronary artery disease, diabetes mellitus type ii, and obesity.The patient was new to pd in (b)(6) 2023 and previously was a hemodialysis patient.

Event Description

It was reported that this male peritoneal dialysis (pd) patient experienced chest pain during their treatment on the liberty select cycler.The patient went to the hospital where they subsequently passed away.Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was in treatment in the early morning of (b)(6) 2023 connected to the liberty select cycler.The patient¿s spouse called the pdrn to state the patient was experiencing chest pain.The patient was in fill 4 of 5.The patient had drained 1,700ml of 2,500ml in the previous drain.It was unknown how much of the fill the patient completed prior to the call.The pdrn advised the spouse to call 911.Emergency medical services (ems) arrived and the pdrn assisted ems via phone with disconnecting the patient from the cycler.The patient was alert and talking during this time.The patient remained alert until they were placed in the ambulance, at which time they became unresponsive.The patient was transported to the hospital.The patient was pronounced deceased in the emergency room (er) at 3:40am.The patient¿s death certificate states the cause of death as end stage renal disease (esrd), cardiac arrest, and respiratory failure.The pdrn stated they reviewed the patient¿s treatment record.The pdrn did not see any alarms prior to the event.The pdrn stated that they had called the patient on the evening of 16/aug/2023, prior to the patient connecting to treatment, as they were attempting to reschedule a kt/v test.They had been trying to reach the patient for several days with no response.The patient¿s treatment had recently been adjusted due to the results of their last kt/v.The patient stated they did not notice any change with the adjustments and did not feel well that evening.The pdrn stated the patient is diabetic and their blood sugars are not controlled.The week before their death, their blood sugar was 1,200 and their records indicated they had been high for the previous six days.During the call the pdrn advised the patient to go to the hospital to be examined.The patient did not go.The pdrn stated the patient has a history of coronary artery disease, diabetes mellitus type ii, and obesity.The patient was new to pd in (b)(6) 2023 and previously was a hemodialysis patient.

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.

Manufacturer Narrative

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.A system air leak and valve actuation test were performed and passed.An (as-received) simulated treatment was performed and completed.The cycler weighed fill volume values were within tolerance for a liberty cycler.There were no visual discrepancies found 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 reported complaint symptom code (no allegation of product deficiency) cannot be confirmed or unconfirmed.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

It was reported that this male peritoneal dialysis (pd) patient experienced chest pain during their treatment on the liberty select cycler.The patient went to the hospital where they subsequently passed away.Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was in treatment in the early morning of (b)(6) 2023 connected to the liberty select cycler.The patient¿s spouse called the pdrn to state the patient was experiencing chest pain.The patient was in fill 4 of 5.The patient had drained 1,700ml of 2,500ml in the previous drain.It was unknown how much of the fill the patient completed prior to the call.The pdrn advised the spouse to call 911.Emergency medical services (ems) arrived and the pdrn assisted ems via phone with disconnecting the patient from the cycler.The patient was alert and talking during this time.The patient remained alert until they were placed in the ambulance, at which time they became unresponsive.The patient was transported to the hospital.The patient was pronounced deceased in the emergency room (er) at 3:40am.The patient¿s death certificate states the cause of death as end stage renal disease (esrd), cardiac arrest, and respiratory failure.The pdrn stated they reviewed the patient¿s treatment record.The pdrn did not see any alarms prior to the event.The pdrn stated that they had called the patient on the evening of (b)(6) 2023, prior to the patient connecting to treatment, as they were attempting to reschedule a kt/v test.They had been trying to reach the patient for several days with no response.The patient¿s treatment had recently been adjusted due to the results of their last kt/v.The patient stated they did not notice any change with the adjustments and did not feel well that evening.The pdrn stated the patient is diabetic and their blood sugars are not controlled.The week before their death, their blood sugar was 1,200 and their records indicated they had been high for the previous six days.During the call the pdrn advised the patient to go to the hospital to be examined.The patient did not go.The pdrn stated the patient has a history of coronary artery disease, diabetes mellitus type ii, and obesity.The patient was new to pd in (b)(6) 2023 and previously was a hemodialysis patient.

• 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: 17650771
• MDR Text Key: 322286289
• Report Number: 0002937457-2023-01316
• 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: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• 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: 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2020
• 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): Hospitalization; Death; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 148 KG