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 Known Impact Or Consequence To Patient (2692)

Event Date 03/15/2020

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.Upon power up, the functional display test failed.When powering on the cycler, the display was dim.It was identified that the cause for dim screen was due to an internal short on the transformer (t1) on the inverter board.The inverter board is located on the rear of the touch screen.A known good inverter board was installed, and the display became fully operational.The functioning inverter board was removed at the completion of the investigation.There were no other visual discrepancies found during the internal inspection.The simulated treatment 15-minute 1000 ml test passed.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 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 went dim during their peritoneal dialysis (pd) treatment.The power cord was plugged into a working outlet.The patient called stating they needed assistance bypassing a drain because they were empty.The fresenius technical support representative advised the assisted the patient to bypassing into fill 1.At that point, it was reported the screen became dim.At that point in time, the technical support representative advised the patient contact to continue use of the cycler and to notify their peritoneal dialysis registered nurse (pdrn) of the event.A replacement cycler was issued to the patient.Additional information was requested but to date, has not been provided.The cycler was returned to the manufacturer.Upon physical evaluation of the cycler by the manufacturer, it was identified that the transformer on the inverter board had an internal short.

• 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: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 9954829
• MDR Text Key: 187452510
• Report Number: 2937457-2020-00651
• 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: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this a Product Problem Report?: Yes
• 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: 03/25/2020
• Device Age: MO
• Date Manufacturer Received: 04/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2008
• 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
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET