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); Pneumonia (2011)

Event Date 03/28/2020

Event Type  Death  

Manufacturer Narrative

Clinical statement: the pdrn confirmed the patient was not in treatment at the time of death and the pneumonia was unrelated to pd therapy, use of the cycler or any other fresenius product(s).Per the information received, this event is unrelated to peritoneal dialysis (pd) therapy or any fresenius device(s) or product(s).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

It was reported that a peritoneal dialysis (pd) patient expired due to a combination of health issues.The patient contact stated patient was on the cycler machine for 12-14 hours a day and it wasn't ridding the body of toxins.Upon follow up with the peritoneal dialysis registered nurse (pdrn), the patient had been experiencing declining health for several months.The patient expired on (b)(6) 2020 from pneumonia.The patient had been treated for two weeks prior to the death with levofloxacin (route, dose, frequency, and duration unknown).The pdrn confirmed the patient was not in treatment at the time of death and the pneumonia was unrelated to pd therapy, use of the cycler or any other fresenius product(s).There was no reported fluid overload.The patient refused to go to the emergency room and the physician could not treat the patient in person.The pdrn stated the death was expected.The patient had previously expressed not having the strength and will to continue fighting disease processes.As a result, the patient was not completing full cycles during treatment and stopping treatments prior to completion.Per the information documented in the file, this event is unrelated to peritoneal dialysis (pd) therapy or any fresenius device(s) or product(s).

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed and showed that the front panel overlay was improperly offset with a gap between it and the bezel.There were no visual indication of particulates within the cassette compartment.A simulated therapy was initiated and completed on the cycler without complication.The weighed fill volumes were found to be within tolerance and fill times were within specification.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.The internal inspection showed the front panel touch screen overlay was improperly not nested in the overlay guide within the inside of the front panel bezel.There were no other 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: 10020835
• MDR Text Key: 189730515
• Report Number: 2937457-2020-00781
• 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: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• 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: 04/28/2020
• Device Age: MO
• Date Manufacturer Received: 06/26/2020
• 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
• Patient Age: 73 YR