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

Catalog Number RTLR180343

Device Problem Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 03/24/2018

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.An investigation of the device manufacturing records was conducted and verified that there were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.In addition, a device history records (dhr) review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

This is a report of a cycler that sparked when it was plugged in prior to setup.Leading up to the event, it was discovered that the cycler¿s power cord was not fully connected.Upon plugging in the cord, the cycler sparked at the connection.The cycler was rebooted and it was noted that the power cord was still somewhat loose.The technical support representative advised the patient to re-setup using all new supplies.Follow up with the patient nurse verified that there was no patient injury or medical intervention required as a result of the spark.There was no noted burn damage to the cycler or around the area of the spark.The patient was able to setup with new supplies and continue with treatment without complication.The cycler has remained in use.Additional information was requested but was not available.

• Brand Name: LIBERTY SELECT 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: 7430134
• MDR Text Key: 105663270
• Report Number: 2937457-2018-01042
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/13/2018

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 Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Initial Date Manufacturer Received: 03/24/2018
• Initial Date FDA Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2014
• 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