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

Catalog Number RTLR180111

Device Problems Use of Device Problem (1670); Overfill (2404)

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

Event Date 09/27/2017

Event Type  malfunction  

Manufacturer Narrative

The cycler was returned for evaluation.Exterior visual inspection showed no signs of physical damage.The internal, visual inspection showed that there were indications of dried fluid inside the cassette compartment.No burrs or sharp edges in cassette area that may have punctured a cassette membrane.A simulated treatment was completed without failures or problems occurring.The cycler weighed fill volume values were within tolerance there were no fluid leaks in the test cassette during the treatment test.Mechanical testing was completed and passed.There was visual evidence of dried fluid within the recess of the bottom cover adjacent to the pump.The cause of the encountered dried fluid could not be determined.The pump head test passed.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 manufacturing review confirmed the labeling, material, and process controls were within specification.

Event Description

A peritoneal dialysis patient reported a large drain during drain 0.The patient drained 3822 ml.He reported that he was not able to complete treatment the night before and had done manuals in between treatment.During follow up the patient's nurse reported that the patient did not have any injury due to the potential over fill.She reported this was a use error.He was impatient in draining for his daytime exchange and did not drain before moving on to a fill.He also did not put into the cycler that he had a day time fill as he was instructed.The patient did not complete treatment on (b)(6) 2017 and when he talked to his nurse he was instructed to do a daytime exchange.He drained 2000 and thought that was fine and then proceeded to fill with 2000 instead of draining everything out to account for his ultra-filtration (uf).Residual fluid, the new manual fill, and the uf of the new fill stacked resulting in the large drain during drain 0 on the cycler.She considers this use error of the manuals and said the cycler did not malfunction, however without treatment data available the malfunction could not be determined for sure.The patient did not require any medical intervention and continues peritoneal dialysis with no complications.The drain volume 3822 ml was 191% of the patient's prescribed fill resulting in a reportable malfunction.The cycler was replaced.

• 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: 6974718
• MDR Text Key: 90763568
• Report Number: 2937457-2017-01073
• 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,health professional
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/24/2017

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: 10/03/2017
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Initial Date Manufacturer Received: 09/27/2017
• Initial Date FDA Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2017
• 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