MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180343

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/16/2022

Event Type  malfunction  

Event Description

A peritoneal dialysis (pd) patient contacted fresenius technical support (ts) to report that the screen of their liberty select cycler went blank, and the device would not turn on.The patient was not connected during the incident.There were no power outages in the area and there were no problems with the outlet.The power switch was in the on position, but the display was blank.The patient tried rebooting the cycler, but the cycler buttons would not light up and no sound was coming from the device when the ok and stop keys were pressed.The ts representative advised the patient to discontinue use of the cycler and they were issued a replacement.The patient was also advised to inform their pd registered nurse (pdrn) of the replacement.The patient was not trained to perform continuous ambulatory peritoneal dialysis (capd) therapy, and they did not have the necessary supplies to do so.Additional information was requested, however, to date a response has not been received.There was no indication of any patient adverse effects or serious injury due to the reported complaint.The cycler was returned to the manufacturer for physical evaluation.Upon evaluation of the cycler by the manufacturer, an internal short was identified on the transformer of the inverter board.

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An exterior visual inspection of the returned cycler showed no signs of physical damage.There were no visual indications of particulates within the cassette area.Upon power up, the cycler touch screen test failed.When powering on the cycler, the ok, stop and up/down arrow push buttons illuminated, however the front panel display remained blank.An internal inspection of the cycler found a short on t1 of the inverter board with lot code 2234 which reflects the transformer has p155 insulation thickness.The inverter board is located on the rear of the front panel assembly.A known good inverter board was installed, and the display became operational.There were visual indications of dried fluid under the pump assembly on the bottom cover.However, there were no burrs or sharp edges in the cassette area that could have punctured a cassette membrane.The cause of the observed dried fluid could not be determined.The cycler underwent and passed a voltage verification check, a valve actuation test, a system air leak test, and a mushroom head check.Additionally, a pre-accelerated stress test (ast) simulated treatment was performed without any failures or problems.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformance's 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 was confirmed and the cause was determined to be an internal short on the transformer of the inverter board.

• Brand Name: LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 19160700
• MDR Text Key: 340789736
• Report Number: 0002937457-2024-00667
• 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: K181108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2024
• Device Age: MO
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2009
• 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