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

Model Number LIBERTY CYCLER

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/26/2018

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the plant¿s investigation.

Event Description

Peritoneal dialysis patient reported to technical port of slow fills during treatment.Patient treatment data was provided and assessed for 150% and 180% iipv and did reveal an episode of increased intraperitoneal volume (iipv).The largest drain volume from this treatment occurred during drain 1 where 5137ml drained.This drain is 244% of the prescribed fill volume.In order to be a reportable malfunction, at least 180% of the prescribed fill volume would have to have been drained.180% of fill volume 2109ml is 3796ml.Therefore, a reportable malfunction has occurred.Follow up with the patient¿s peritoneal dialysis patient indicates that the patient completed treatment with continuous ambulatory peritoneal dialysis and resumed treatment on a replacement cycler.No complications were reported.

Manufacturer Narrative

Plant investigation: the reported complaint symptom iipv (dv > 200% of fv) was not confirmed.The reported complaint symptom filling slowly was not confirmed.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 no indications of dried fluid inside the cassette compartment.No burrs or sharp edges in cassette area that may have punctured a cassette membrane.A simulated treatment was completed without any failures or problems occurring.The cycler weighed fill volume values were within tolerance for a liberty cycler.The fill times were within the time specifications for a liberty cycler.There were no fluid leaks in the test cassette during the treatment test.The system air leak test passed.The valve actuation test passed.The load cell verification was within tolerance.The internal inspection showed indications of a spot 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.Mushroom head check passed.Tested negative for glucose.An investigation of the product history records was conducted by the manufacturer.There were no deviations or non-conformance's during the manufacturing process.In addition, the product history review confirmed the labeling, material, and process controls were within specification.

Event Description

".".

• 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
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7570969
• MDR Text Key: 110170434
• Report Number: 2937457-2018-01571
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/12/2018

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 Model Number: LIBERTY CYCLER
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Device Age: MO
• Initial Date Manufacturer Received: 05/26/2018
• Initial Date FDA Received: 06/05/2018
• Supplement Dates Manufacturer Received: 06/28/2018
• Supplement Dates FDA Received: 07/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1