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

Catalog Number RTLR180343

Device Problems Thermal Decomposition of Device (1071); Charred (1086); Image Display Error/Artifact (1304)

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

Event Date 02/11/2018

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed with no physical damage noted.Upon turning on the cycler, the display was dim at the maximum brightness setting.An internal inspection of the cycler identified that the cause for the display issue was due to a burnt j2 connector on the inverter board that connects to the display.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.Upon completion of the evaluation, the reported issue of a burning smell and dimmed display was confirmed and the cause was determined to be a faulty inverter board with a burnt j2 connector.The cycler was refurbished following the evaluation and the inverter board was replaced.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the screen of a patient¿s liberty cycler began to dim during drain three of four of the patient¿s peritoneal dialysis therapy.The patient had drained 505ml of an expected 1800ml at the time of the event.It was noted that as the display began to dim, there was a burning smell coming from the cycler.The cycler was plugged directly into a power outlet and there had not been any recent power outages at that location.The technical support representative advised the patient to discontinue use of the cycler and to notify their peritoneal dialysis registered nurse of the event.The patient had manual supplies to continue their treatment without the cycler.The cycler was returned to the manufacture.Upon evaluation, it was identified that the j2 connector that goes to the display was burnt.The inverter board was replaced as a result of the damage.At this point in time, there has been no report of patient injury or medical intervention required as a result of the event.Additional information was requested but was unavailable.

• 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: 7306316
• MDR Text Key: 101478860
• Report Number: 2937457-2018-00637
• 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: 03/01/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Initial Date Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 03/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2008
• 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