MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Model Number	180237
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	12/16/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Clinical review: there is a temporal relationship between pd therapy on the liberty pdx cycler and the patient event of death.However, there is no documentation in the 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.This patient has a recent history of multiple myocardial infarctions and the reported cause of death was cardiac related.All dialysis patients are at an increased risk for mortality with the greatest cause of death being cardiac disease and approximately 20% attributed to acute myocardial infarction.Based on the available information and no allegation of a malfunction or deficiency, the liberty pdx cycler can be excluded as the cause of the patient¿s death.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 or Problem Description
A peritoneal dialysis registered nurse (pdrn) for a patient on pd therapy reported that the patient expired during treatment.Additional information was obtained through follow-up with the pdrn.The patient was in treatment when they expired in their sleep.The patient was already deceased when they were found.No resuscitative efforts were performed, and the patient was not transported to the hospital.The cause of death is suspected to be cardiac in nature.The patient had a recent history of multiple myocardial infarctions unrelated to use of any fresenius products.There were no reported issues with the liberty pdx cycler prior to the death.
Additional Manufacturer Narrative
Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed with no physical damage noted.There were visual indication of particulates in the cycler.A simulated therapy was initiated and completed on the cycler without complication.The weighed fill volumes were found to be within tolerance.The cycler underwent system air leak and valve actuation testing and was found to meet product specifications.Load cell verification testing was performed with no issues noted.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)
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 9526853
• Report Number: 2937457-2019-03655
• Device Sequence Number: 14128974
• Product Code: FKX
• UDI-Device Identifier: 00840861100989
• UDI-Public: 00840861100989
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K181108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 180237
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Device Age: MO
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 01/02/2020; 02/18/2020
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 01/07/2020; 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELFLEX PD FLUID; LIBERTY CYCLER SET ; DELFLEX PD FLUID; LIBERTY CYCLER SET
• Outcome Attributed to Adverse Event: Death
• Patient Age: 69 YR