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

Model Number 180343

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

Clinical statement: based on the available information, 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.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

It was reported that a peritoneal dialysis (pd) patient discovered a fluid leak on the inside of the cassette door of their cycler after ending their pd treatment.The patient reported slow draining and receiving an air detected in cassette alarm during drain 4 of 6 of treatment and the treatment was cancelled.It is unknown at which point in therapy the leak may have begun.The cause of the leak is unknown.Fluid did come in contact with cycler.The patient was advised to discontinue the use of their cycler and follow up with their peritoneal dialysis nurse (pdrn).A new cycler was issued to the patient.It was reported that an alternate treatment option was available.Upon follow up, the patient confirmed the reported event.The patient stated experiencing an internal leak during manual treatment and contacted the doctor.The doctor recommended lowering the prescribed fill volume for a few weeks.The patient did not develop any additional symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and stated being able to complete peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd) in the absence of the cycler.The patient has received the replacement cycler and is continuing with peritoneal dialysis on the new cycler without issue and without reoccurrence of the reported event.The patient confirmed that the cycler set was discarded and not available to be returned to the manufacturer for physical evaluation, however, the old cycler is available to be picked up and returned.

Manufacturer Narrative

Additional information: d10, h3 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.There were no visual indication of particulates within the cassette area.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.A post accelerated stress test (ast) 2 hour 15 min 8500 ml simulated treatment was performed and completed without alarms or failures.The cycler underwent and passed a 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 beneath the mushroom heads of pump a and b,on the rear panel near the speaker, and within the recess of the bottom cover adjacent to the pump.Fluid was found in the hp3 filter during the inspection.The cause of the fluid and 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: 11096850
• MDR Text Key: 224772792
• Report Number: 2937457-2020-02358
• 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
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem 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: 01/22/2021
• Device Age: MO
• Date Manufacturer Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Age: 52 YR
• Patient Weight: 90