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); Overfill (2404)

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

Event Date 04/21/2019

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 following a report of the patient receiving several air detected in cassette alarms during drain 1 of treatment.A review of the patient¿s treatment records identified that the patient drained 6212 ml during drain 1 of 4 of the treatment.This drain volume is 259% the patient's prescribed fill volume of 2400 ml.The patient also reported moisture in the cassette door after they removed the cassette.As a result of the iipv and the fluid leak 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, the patient did not experience any 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 the patient was 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 continuing with peritoneal dialysis on the new cycler without issue and without reoccurrence of the reported event.The cassette was available to be returned to the manufacturer for physical evaluation.The old cycler has been picked up and returned.

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.An (as received) simulated treatment was performed and completed without failures.The cycler weighed fill volume values were within tolerance for a liberty cycler.There were no fluid leaks in the test cassette during the treatment test.The load cell verification was within tolerance.The cycler underwent and passed a system air leak test, valve actuation test, and patient sensor calibration check.The go/ no go gauge check passed.An investigation of the cycler mushroom heads verified that the surface conditions and alignments were within specification.The cycler tested positive for glucose.An internal visual inspection identified evidence of dried fluid beneath the mushroom heads of pump a and b and within the recess of the bottom cover adjacent to the pump.The cause of the 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; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 8549416
• MDR Text Key: 143085738
• Report Number: 2937457-2019-01198
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 05/06/2019
• Device Age: MO
• Initial Date Manufacturer Received: 04/21/2019
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 06/10/2019
• Supplement Dates FDA Received: 06/13/2019
• 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: 67 YR
• Patient Weight: 67