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 Known Impact Or Consequence To Patient (2692)

Event Date 06/27/2019

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 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 dim, even when the brightness setting was at 10.It was identified that the cause for the dim screen was due to an internal short present 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.A simulated treatment was performed and passed.The cycler passed voltage check.There were no loud or unusual noised heard during testing.An internal visual inspection of the returned cycler encountered no other discrepancies.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 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 drain one of three of their peritoneal dialysis (pd) treatment.The cycler was plugged into the socket properly.The cycler was rebooted and the power fail recovery failed message occurred, however the screen was blank.There was a electrical buzzing noise that occurred when the screen went dim.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.Upon follow up, the pdrn confirmed that there were no adverse events or medical intervention required as a result of the reported event.The patient did not complete treatment.The cycler was returned to the manufacturer and a replacement cycler was provided and received.Upon physical evaluation of the cycler by the manufacturer, evidence of an internal short on the transformer on the inverter board was identified.

• Brand Name: LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 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: 8896534
• MDR Text Key: 154407019
• Report Number: 2937457-2019-02579
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• 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: 07/10/2019
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 08/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2017
• 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