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

Catalog Number RTLR180343

Device Problems Fluid/Blood Leak (1250); Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/07/2019

Event Type  malfunction  

Manufacturer Narrative

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 cancelling set up during their pd treatment.The patient reported receiving a system not properly calibrated message after rebooting the cycler and the treatment was cancelled.The cause of the leak is unknown.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 pdrn stated that the patient was in treatment and decided to disconnect because of the alarms.When breaking down the cycler, a hole was discovered in the cassette and fluid leaked everywhere including in the cycler.The cycler sparked and the lights flickered.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.Further follow up with the patient confirmed that the patient has received a new cycler which is working well and is continuing peritoneal dialysis therapy with no further issues.The cassette used by the patient was discarded and is not available for return for physical evaluation by the manufacturer.The cycler was returned to the manufacturer for physical evaluation.

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.The reported symptom (spark) was not confirmed.There was no evidence of an electrical failure.There were visual indications 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.When powering on the cycler, "system is not properly calibrated" message was displayed.An accelerated stress test (ast) test was performed and failed as a grinding noise was traced to the motor pump a.There were no fluid leaks in the test cassette during the accelerated stress test.The cycler underwent and passed a system air leak test, valve actuation test, catch post hipot test, patient hipot test, voltage test and post-ast 2 hour 15 min 8500 ml simulated treatment.An internal visual inspection of the cycler found visual evidence of dried fluid under pump ¿a¿ and ¿b¿ mushroom head and within the recess of the bottom cover adjacent to the pump.There was a small amount of fluid in the bottom of the cycler.The cause of the observed dried fluid and fluid could not be determined.An investigation of the cycler mushroom heads verified that the surface conditions and alignments were within specification.The cycler tested positive for glucose.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.

• Brand Name: LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 8570326
• MDR Text Key: 144144950
• Report Number: 2937457-2019-01288
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Device Age: MO
• Date Manufacturer Received: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Age: 22 YR
• Patient Weight: 54