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

Model Number LIBERTY SELECT CYCLER

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/23/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Peritoneal dialysis patient contact reported to technical service during troubleshooting that the patient encountered a fluid leak coming from the patient¿s catheter site.The patient contact reported that the patient¿s physician informed the patient the cause of the fluid leak was due to the patient being overfilled with by the cycler.Patient treatment details was provided and reviewed for potential increased intraperitoneal volume (iipv).The 150% fill criterion was not exceeded and no drain volumes exceeded the criterion of 180% of the fill volume.All drain volumes met the minimum 70% fill volume criterion as well.Treatment data indicates there is no reportable malfunction.Follow up with the patient¿s peritoneal dialysis nurse indicates that there was no medical intervention required as a result of the alleged event.The patient¿s treatment prescription was updated to eliminate a last fill.The patient¿s fill volume has also been updated to address the patient¿s catheter site leakage.Patient has resumed treatment with no complications.

Event Description

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Manufacturer Narrative

The reported complaint symptom iipv (dv up to 180% of fv) was not confirmed.The reported complaint symptom (draining slowly) 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 drain times were within the time specifications 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.An investigation of the product history records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the product history review confirmed the labeling, material, and process controls were within specification.

Manufacturer Narrative

There is a temporal relationship between the patient event of fluid coming out of the catheter site with subsequent treatment prescription change and pd therapy on the liberty select cycler.There is no documentation to show a causal relationship between the leaking fluid at the catheter site and the liberty select cycler.The treatment data does not indicate a malfunction.A supplemental report will be submitted upon completion of the plant¿s investigation.

• 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: 7509759
• MDR Text Key: 108084472
• Report Number: 2937457-2018-01325
• 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,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/19/2018

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 SELECT CYCLER
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Device Age: MO
• Initial Date Manufacturer Received: 04/23/2018
• Initial Date FDA Received: 05/13/2018
• Supplement Dates Manufacturer Received: 05/16/2018; 05/18/2018
• Supplement Dates FDA Received: 05/17/2018; 05/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX 1.5%; LIBERTY CYCLER SET; PD SOLUTION