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 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Peritoneal dialysis nurse requested a replacement liberty select cycler after reported that a peritoneal dialysis patient encountered a high manual drain after completing peritoneal dialysis treatment.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 (manual stat drain) where 4100ml drained.This drain is 205% 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.A 180% of fill volume 2000ml is 3600ml.Therefore, a reportable malfunction has occurred.Follow up with the peritoneal dialysis nurse indicates that the patient did not experience any complications as a result of the alleged event.Patient resumed treatment with continuous ambulatory peritoneal dialysis.The patient is scheduled to see a surgeon to determine if the drain complications are catheter related.The patient reportedly drains well when performing continuous ambulatory peritoneal dialysis.The liberty select was replaced.

Event Description

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Manufacturer Narrative

The reported complaint symptom iipv (dv > 200% of fv) 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 load cell verification was within tolerance.The system air leak test passed.The valve actuation test passed.There were no discrepancies encountered in the internal inspection of the cycler.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: 7579802
• MDR Text Key: 110465325
• Report Number: 2937457-2018-01645
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/26/2018

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: 07/06/2018
• Device Age: MO
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 06/07/2018
• Supplement Dates Manufacturer Received: 07/24/2018
• Supplement Dates FDA Received: 07/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIBERTY CYCLER SET; PD SOLUTION