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

Model Number 180343

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 05/09/2020

Event Type  malfunction  

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 visual indications of dried fluid within the cassette compartment.There were no visual indications of particulates, burrs, or sharp edges 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 touch screen remained blank.It was identified that the cause for the blank screen was due to an internal short present transformer (t1) on the inverter board.The inverter board is located on the rear front panel assembly.A known good inverter board was installed and the display became fully operational.There were visual indications of dried fluid under the pump assembly on the bottom cover.The cause of the observed dried fluid could not be determined.No other discrepancies noted during the internal inspection.The cycler underwent and passed a voltage check and mushroom head checks.A review of the device manufacturing records was conducted by the manufacturer.A device history record (dhr) review was performed and a prior occurrence of a dim screen was found.During rework the dim screen was found to be caused by a defective inverter board.The board and a damaged pump door were replaced.The cycler underwent a post-accelerated stress test and passed.No other discrepancies were identified in the dhr and there were no other deviations or non-conformances during the manufacturing process.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 of the transformer on the inverter board.The cycler was refurbished following the evaluation.

Event Description

It was reported that the screen of a patient¿s liberty select cycler appeared distorted and blank during power up prior to their peritoneal dialysis (pd) treatment.At that point in time, the technical support representative advised the patient to discontinue use of the cycler and to notify their peritoneal dialysis registered nurse (pdrn) of the event.A replacement cycler was issued to the patient.It was reported that an alternate treatment option was available.Additional information was requested, however, to date a response has not been received.Upon physical evaluation of the cycler by the manufacturer, evidence of an internal short on the transformer on the inverter board was identified.

Event Description

It was reported that the screen of a patient¿s liberty select cycler appeared blank during power up prior to their peritoneal dialysis (pd) treatment.At that point in time, the technical support representative advised the patient to discontinue use of the cycler and to notify their peritoneal dialysis registered nurse (pdrn) of the event.A replacement cycler was issued to the patient.It was reported that an alternate treatment option was available.Additional information was requested, however, to date a response has not been received.Upon physical evaluation of the cycler by the manufacturer, evidence of an internal short on the transformer on the inverter board was identified.

Manufacturer Narrative

Corrected information: b5 (distorted screen was incorrect description of screen issue.Identified during review of initial customer call).

• 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
• MDR Report Key: 10094053
• MDR Text Key: 192265403
• Report Number: 2937457-2020-00949
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K181108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• Device Operator: Lay User/Patient
• Device Model Number: 180343
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• Device Age: MO
• Date Manufacturer Received: 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1