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 05/07/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A peritoneal dialysis patient reported receiving an unknown alarm during the drain cycles of therapy.Treatment data was provided.Treatment data was assessed for 150% and 180% iipv and did reveal an episode of increased intraperitoneal volume (iipv) on (b)(6) 2018.The largest drain volume from this treatment occurred on during drain 4 where 2662ml 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.The 180% of fill volume 1301ml is 2341.Follow up with the patient¿s peritoneal dialysis nurse confirmed the patient did not experience any complications as a result of the event.No treatments were reported missed.The patient has resumed therapy on the replacement cycler.

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.A visual inspection of the returned cycler exterior showed no sign of physical damage.A simulated treatment was performed and completed on the cycler with no issues noted.The load cell verification was performed and passed.The cycler underwent system air leak and valve actuation testing and was found to meet product specifications.The cycler weighed fill volume values were within tolerance.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: 7544779
• MDR Text Key: 109386842
• Report Number: 2937457-2018-01450
• 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
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LIBERTY SELECT CYCLER
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Device Age: MO
• Date Manufacturer Received: 06/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD SOLUTION; LIBERTY CYCLER SET
• Patient Age: 59 YR
• Patient Weight: 73