MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY CYCLER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180111

Device Problem Overfill (2404)

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

Event Date 11/23/2016

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi): (b)(4) - a follow-up mdr will be submitted following evaluation.

Event Description

A peritoneal dialysis patient reported ultrafiltration of 2000 milliliters during drain 5.Upon the review of the treatment data, an event of increased intraperitoneal volume (iipv) was found.The reported drain volume of 4305ml in drain 5 was 187% of the expected drain volume which resulted in a reportable device malfunction.Follow up with the patient¿s peritoneal dialysis nurse confirmed there were no serious injuries or complications.The patient continued performing continuous cycler-assisted peritoneal dialysis.Drain 0 5ml fill 1: 2299ml drain 1: 1934ml uf -365ml fill 2: 2305ml drain 2: 2172ml uf -499ml fill 3: 2305ml drain 3: 1677ml uf -1128ml fill 4: 2305ml drain 4: 2289ml uf -1145ml fill 5: 2305ml drain 5: 4305ml uf 854ml uf=ultrafiltration.

Manufacturer Narrative

The actual device was evaluated by the manufacturer for physical evaluation.An external, visual inspection of the returned cycler exterior showed no signs of any physical damage.A simulated treatment was completed without any failures or problems occurring.The cycler weighed fill volume values were within tolerance.The complaint symptoms could not be reproduced during testing.The valve actuation test passed.The system air leak test passed.The patient sensor calibration check passed.The load cell verification passed.The teach pumps test passed.The internal, visual inspection of the cycler encountered no discrepancies.Additionally, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the device history record review confirmed the labeling, material, and process controls were within specification.

• Brand Name: LIBERTY CYCLER
• 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: 6182822
• MDR Text Key: 62690615
• Report Number: 2937457-2016-01243
• Device Sequence Number: 1
• Product Code: FKX
• 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,health professional
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 01/20/2017

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 Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Initial Date Manufacturer Received: 11/26/2016
• Initial Date FDA Received: 12/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2015
• 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
• Treatment: LIBERTY CYCLER CASSETTE; PD FLUID
• Patient Weight: 113