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 Problems Dyspnea (1816); Pain (1994)

Event Date 02/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4 - the liberty cycler was received at the plant and the cycler passed all mechanical testing and treatment simulations.There were no discrepancies encountered in the internal inspection of the cycler.The allegation was not confirmed.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 record review confirmed the labeling, material, and process controls were within specification.

Event Description

On (b)(6) 2017 the peritoneal dialysis patient cancelled the treatment due to a solution temperature high alarm.On (b)(6) 2017 the patient reported pain and difficulty breathing during fill 1 of the peritoneal dialysis treatment.Treatment details for the patient indicated that the patient had filled with 1999ml during fill 3 on (b)(6) 2017 and did not drain the remaining 2000ml during drain 0 on (b)(6) 2017 and the patient had filled with an additional 2000ml during fill 1.The patient drained 3883ml during drain 1.The additional 2000ml resulted in an increased intraperitoneal volume (iipv).Treatment details for (b)(6) 2017: fill 1: 1999ml drain 1 3889ml this reported drain volume of 3889ml is 195% over the expected drain volume which is a reportable malfunction.The patient did not require medical intervention or treatment as a result of the overfill.The cycler was replaced and the patient is performing treatments on the replacement cycler.

• 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: 6414815
• MDR Text Key: 70315410
• Report Number: 2937457-2017-00182
• 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
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• 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: 02/28/2017
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 02/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2009
• 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: DELFLEX PD SOLUTION; LIBERTY CYCLER CASSETTE