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

Catalog Number RTLR180111

Device Problem Overfill (2404)

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

Event Date 07/03/2019

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

This is a report of a patient who experienced an increased intraperitoneal volume (iipv) event coincident with peritoneal dialysis (pd) therapy.The event was discovered while reviewing the patient¿s treatment records following a report of a patient having a scale reading error message during fill 1 of 3 of their pd treatment.A review of the patient¿s treatment records identified that the patient drained 5183 ml during drain 1 of the treatment.This drain volume is 206% the patient's prescribed fill volume of 2500 ml.As a result of the iipv event, the technical support representative advised the patient to discontinue use of the cycler and to notify their peritoneal dialysis registered nurse (pdrn) of the event.Upon follow up with the pdrn, they had no specific information regarding the event because they were unaware of it.However, the pdrn stated they were not aware of any patient injury, adverse event, or medical intervention required as a result of the reported event.Additional information has been requested but to date, has not been provided.

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed with no physical damage noted.There were no indications of dried fluid inside the cassette compartment.There were no burrs or sharp edges in cassette area that may have punctured a cassette membrane.The go/ no go gauge check passed.A simulated therapy was initiated and completed on the cycler without complication.The weighed fill volumes were found to be within tolerance.There were no fluid leaks in the test cassette during the treatment test.The cycler underwent system air leak and valve actuation testing and was found to meet product specifications.A patient sensor calibration test was also performed and the cycler was found to be within tolerance.Load cell verification testing was performed with no issues noted.The internal inspection showed that there was dried fluid on the bottom cover between the front panel assembly and the pump assembly.The cause of the encountered dried fluid could not be determined.The mushroom head check passed.The cycler tested negative 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.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: UL LIBERTY CYCLER ASSEMBLY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 8812131
• MDR Text Key: 151742777
• Report Number: 2937457-2019-02250
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• Combination Product (y/n): N
• PMA/PMN Number: K123630
• 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: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Device Age: MO
• Date Manufacturer Received: 07/26/2019
• 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 Age: 61 YR
• Patient Weight: 116