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

Model Number LIBERTY SELECT

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/20/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Peritoneal dialysis patient report provided treatment to technical support during troubleshooting of the liberty select.The treatment data was 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 3 where 3284ml drained.This drain is 187% 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 the prescribed fill volume of 1753ml is 3155ml.Therefore, a reportable malfunction has occurred.The patient was advised to discontinue use of the liberty select and to contact the clinic nurse.The patient reported that since there is no continuous ambulatory peritoneal dialysis supplies, that the patient would continue use of the cycler until a replacement was delivered.Additional information was solicited.The liberty select was replaced.

Event Description

".".

Manufacturer Narrative

The reported complaint symptom (dc drain complication encountered) was not confirmed.The reported complaint symptom (iipv (dv > 180% to 200% of fv) was not confirmed.The reported complaint symptom (scale reading error warning) was not confirmed.A visual inspection of the returned cycler exterior showed no signs of physical damage.An (as-received) simulated treatment was performed and completed without failures.The cycler weighed fill volume values were within tolerance for a liberty cycler.The system air leak test passed.The valve actuation test passed.The load cell verification was within tolerance.There were no discrepancies encountered in the internal inspection of the cycler.

• 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: 7504047
• MDR Text Key: 108146660
• Report Number: 2937457-2018-01306
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K171652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LIBERTY SELECT
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Was the Report Sent to FDA?: No
• Device Age: MO
• Date Manufacturer Received: 06/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIBERTY CYCLER SET; PD SOLUTION