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 Problem No Information (3190)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. clinical investigation: on 13/oct/2020 a patient contact for a patient on peritoneal dialysis (pd) contacted fresenius technical support for a patient line blocked message during treatment on the liberty select cycler in the hospital.Attempts to obtain additional information regarding the hospitalization were unsuccessful.The reason for the patient¿s hospitalization is unknown; however, there is no allegation of a device malfunction or deficiency or reported peritoneal dialysis (pd) issue related to the hospitalization.There is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.

Event Description

A patient contact reported that a peritoneal dialysis (pd) patient was receiving a patient line is blocked message on a hospital cycler.The reason for hospitalization is unknown.Additional information was requested regarding the hospitalization, however; to date has not been provided.

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.Although there was evidence of dried fluid present within the cassette compartment, there were no burrs or sharp edges in the cassette area that could have punctured the cassette membrane.There were no visual indications of particulates within the cassette area.An as-received simulated treatment was performed and completed without failures.The cycler weighed fill volume values were within tolerance for a liberty cycler.No fluid leaks in the test cassette during the treatment test.The cycler underwent and passed a system air leak test, valve actuation test, load cell verification test, and patient sensor calibration check.An investigation of the cycler mushroom heads verified that the surface conditions and alignments were within specification.An internal visual inspection identified evidence of dried fluid within the recess of the bottom cover adjacent to the pump, on the bottom cover behind the front panel assembly, and on the inside of the top cover.The cause of the observed dried fluid could not be determined.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: 10757884
• MDR Text Key: 213872510
• Report Number: 2937457-2020-01962
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• 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: 01/13/2021
• Device Age: MO
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization