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 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

The reported symptom (iipv ((dv > 200% of fv) was not confirmed.The reported symptom balloon valve leak warning was not confirmed.Encountered dc drain complication encountered.There was visual evidence of liquid within pneumatic filter hp1.The hp1 filter was replaced.After replaced the clogged hp1 the simulated treatment was performed, completed without any failures or problems.The cycler weighed fill volume values were within tolerance.The system air leak passed.The voltage check passed.The load cell value and verification was within tolerance.A visual inspection of the returned cycler exterior showed no sign of physical damage.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.

Event Description

Peritoneal dialysis patient contact reported during troubleshooting with technical support that the patient experienced high drain volumes.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 4 where 4499ml drained.This drain is 214% 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 2106ml is 3791ml.Therefore, a reportable malfunction has occurred.The patient was advised to cancel treatment and to contact the clinic nurse.The liberty cycler was replaced.Additional information was solicited.

• 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: 7500655
• MDR Text Key: 107828722
• Report Number: 2937457-2018-01292
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2018

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: 04/26/2018
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2011
• 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