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

Catalog Number RTLR180343

Device Problem Overfill (2404)

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

Event Date 04/11/2019

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 that was in drain 2 for over two and a half hours.It was reported the cycler was not moving to fill 3.No alarms were reported.The patient discontinued treatment during due to a large drain.A review of the patient¿s treatment records identified that the patient drained 10479 ml during drain 2 of the treatment.This drain volume is 420% the patient's prescribed fill volume of 2497 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, it was confirmed that the patient did not experience any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient received a scale reading error warning during drain 2.The patient has received a new cycler which is working well.The old cycler is scheduled to be returned.

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 that was in drain 2 for over two and a half hours.Scale reading error warnings during the drain were reported.It was reported the cycler was not moving to fill 3.The patient discontinued treatment during due to a large drain.A review of the patient¿s treatment records identified that the patient drained 10479 ml during drain 2 of the treatment.This drain volume is 420% the patient's prescribed fill volume of 2497 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, it was confirmed that the patient did not experience any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient has received a new cycler which is working well.

Manufacturer Narrative

Plant investigation: a visual inspection of the returned cycler exterior showed that the front panel bezel gasket was drooping approximately.5 inches over the center of the front panel overlay.This does not obstruct the view or the functionality of the touch screen.There were visual indications of dried fluid within the cassette compartment.There were visual indications of particulates within the cassette area.There were no burrs or sharp edges in cassette area that may have punctured a cassette membrane.A simulated treatment was performed and completed without failures.The cycler weighed fill volume values were 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.Load cell verification testing was performed with no issues noted.A review of the device manufacturing records was conducted by the manufacturer.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 positive for glucose.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; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 8537049
• MDR Text Key: 142677393
• Report Number: 2937457-2019-01167
• 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,Followup
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• 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: 04/24/2019
• Device Age: MO
• Date Manufacturer Received: 05/07/2019
• 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: 74 YR