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); Myocardial Infarction (1969); Electrolyte Imbalance (2196)

Event Date 01/03/2021

Event Type  Death  

Manufacturer Narrative

Clinical investigation: there is a temporal relationship between peritoneal dialysis (pd) therapy utilizing the liberty select cycler and the patient event of unresponsiveness with subsequent death.However, there is no documentation in the complaint file to show a causal relationship between the death and utilization of the liberty select cycler.The patients cause of death was reported as a heart attack due to the patients non-compliance with taking prescribed potassium.Low potassium is a frequent problem in peritoneal dialysis patients which is associated with increased cardiovascular and overall mortality.The physician stated the death was not related to use of the liberty select cycler.Based on the available information and no allegation of a device malfunction or deficiency, the liberty select cycler can be excluded as the cause of the patients death.

Event Description

A peritoneal dialysis registered nurse (pdrn) contacted fresenius customer service and reported that this pd patient passed away the previous night.The pdrn stated that the patient was connected to the liberty select cycler at the time of death and the cause of death was unknown.Additional information was obtained through follow-up with the pdrn.The patient was in active treatment on the liberty select cycler when their spouse found them unresponsive.The spouse called 911 and emergency medical services (ems) arrived at the home.Ems worked on the patient at the home, however the patient could not be revived.The patient had a do not resuscitate (dnr) order, however the paperwork could not be located at the time of the event.The physician has documented the cause of death as a heart attack due to the patient not taking their prescribed potassium.The physician stated the death was unrelated to use of the liberty select cycler, pd therapy or other fresenius product(s).

Manufacturer Narrative

Additional information: d10, h3: 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

Correction: g5, h6 - patient code.

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer.An external visual inspection showed that paint on the heater tray was damaged.There was dried fluid within the cassette compartment.There were no particulates within the cassette area.There were no burrs or sharp edges in the cassette area that could have punctured the cassette membrane.A post- accelerated stress test (ast) simulated treatment was initiated and completed without failures.The cycler underwent and passed a system air leak test, load cell verification check valve actuation test, and mushroom head check.An internal visual inspection of the cycler found dried fluid under pump b mushroom head, on the inside of the top cover, on the bottom cover under the pump assembly, and on the baseplate under the pump assembly.The cause of the observed dried fluid could not be determined.There were no other visual discrepancies observed during the internal inspection.Upon completion of the evaluation, no malfunctions were found that could have caused or contributed to the reported event.The cycler performed as designed and an associated cause could not be determined.The cycler was refurbished following the evaluation.

• 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: 11155208
• MDR Text Key: 226276520
• Report Number: 2937457-2021-00060
• 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,Followup
• Report Date: 03/04/2021

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
• Date Returned to Manufacturer: 02/09/2021
• Device Age: MO
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 01/12/2021
• Supplement Dates Manufacturer Received: 01/19/2021; 01/28/2021; 02/23/2021
• Supplement Dates FDA Received: 01/21/2021; 02/08/2021; 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID.; DELFLEX PD FLUID.; LIBERTY CYCLER SET.; LIBERTY CYCLER SET.; DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Death
• Patient Age: 83 YR