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 Death (1802); Uremia (2188)

Event Date 07/11/2020

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 continuous cycling peritoneal dialysis (ccpd) therapy on the liberty select cycler and the adverse of event of uremia requiring hospitalization.It is within reason to believe the patient¿s uremia was due to a declination of residual renal function as the patient¿s renal disease process advanced beyond the benefit of dialysis.Though the patient had been on renal replacement therapy for esrd for approximately a year and a half, it is well known that renal disease in its advanced stages carries the inability to replace the work of a native human kidney, leading to hospitalizations and a multitude of comorbidities.It is unknown if a temporal relationship exists between hd therapy and the patient¿s death, as there was no report whether the patient was actively undergoing renal replacement therapy at the time they expired.It is within reason to believe this patient¿s death may have been attributed to multiple comorbidities as reported by the pdrn.It is well-known that heart disease is a major contributing factor in the mortality of esrd patients.Additionally, esrd in the environment of multiple comorbidities has shown to have a negative impact on survival.Due to the limited information received, the cause of death and any relationship to pd and hd therapy utilizing fresenius product(s) or device(s) cannot be determined at this time.Based on the available information there was no specific allegation or objective evidence a fresenius product deficiency or malfunction caused or contributed to the patient¿s death.

Event Description

A nurse reported that a peritoneal dialysis (pd) patient passed away.The cause of death was unknown at the time of the report.Upon follow up, the patient¿s peritoneal dialysis registered nurse (pdrn) reported this patient expired in the hospital on (b)(6) 2020 due to an unknown cause.The patient was admitted to the hospital on (b)(6) 2020 for uremia associated with worsening end-stage renal disease (esrd) which caused an unresponsiveness to pd therapy.The patient was placed on hemodialysis (hd) therapy on a hospital provided hd device (brand and model unknown) because of the unresponsiveness to pd therapy.It was unknown if the patient was undergoing hd therapy at the time of death.Additionally, the cause and events leading to the patient¿s death were unable to be provided.It was reported the patient¿s death was likely attributed to the patient¿s multiple comorbidities, most notably worsening esrd with atherosclerotic heart disease.There was no report that this patient¿s death was due to a deficiency or malfunction of the liberty select cycler or 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.

Manufacturer Narrative

Additional information: d10, h3, h6 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.They cycler underwent and passed a system air leak test, valve actuation test, and the load cell verification was within tolerance.There were no discrepancies encountered in the internal inspection of the cycler.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
• MDR Report Key: 10409256
• MDR Text Key: 202993085
• Report Number: 2937457-2020-01469
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K181108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 180343
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Device Age: MO
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID.; LIBERTY CYCLER SET. ; DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 73