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 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 having patient sensors too high alarms.The patient¿s peritoneal dialysis registered nurse (pdrn) discontinued treatment during drain 2 of 7 due to the large drain.A review of the patient¿s treatment records identified that the patient drained 3736 ml during drain 2 of the treatment.This drain volume is 737% of the patient's largest fill volume of 507 ml.By the time treatment was ultimately cancelled, the drain volume had increased to 4184 ml.The pdrn indicated that the patient started treatment with extreme fluid overload (hadn't dialyzed in days) and they weren't surprised at the large drainage volume.As a result of the iipv event, the technical support representative advised the pdrn to discontinue use of the cycler.Additional information was requested, however 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.The reported patient sensors too high warning was not confirmed.Encountered a balloon valve leak warning.There were visual indications of dried fluid within the cassette compartment.There were no burrs or sharp edges in cassette area that may have punctured a cassette membrane.During the simulated treatment setup, a balloon valve leak occurred.Internal inspection found fluid/ dried fluid in hp1 and hp2 filters within the pump assembly.Replaced the hp1 filter.There were indications of dried fluid within the recess of the bottom cover adjacent to the pump.The cause of the encountered dried fluid could not be determined.After replacing the hp1 filter, 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 cycler underwent and passed system air leak testing and valve actuation testing.Load cell verification testing was performed with no issues noted.The mushroom head check passed and 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.Upon completion of the evaluation, there were no malfunctions that could have caused or contributed to the reported event 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: 8545704
• MDR Text Key: 143603344
• Report Number: 2937457-2019-01188
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Device Age: MO
• Date Manufacturer Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET