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 04/21/2019

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 ok, stop and up/down arrows illuminated; however, the front panel remained blank.It was identified that the cause for the blank 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.The bracket that holds the inverter board was cracked.A known good inverter board was installed and the display became fully operational.The functioning inverter board was removed from the touch screen at the completion of the investigation.An internal visual inspection of the returned cycler encountered no other discrepancies.A review of the device manufacturing records was conducted by the manufacturer.The load cell verification test was within tolerance and passed.There were no deviations or non-conformances during the manufacturing process related to the reported symptom code(s).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 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 displayed an invalid sensor reading warning and then the screen went blank, during their peritoneal dialysis (pd) treatment; cycle and phase unknown.The ok, and stop keys were illuminated and the cycler was plugged into an extension cord shared with a lamp.Power cord connection behind the cycler was secure.The patient plugged the cycler into a power outlet, but the screen remained blank.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.It was reported that an alternate treatment option was available.Upon follow up, the (pdrn) confirmed there were no adverse events or medical intervention required as a result of the reported event and the patient was able to complete treatment manually.The cycler was returned to the manufacturer and a replacement cycler was provided and received.Upon physical evaluation of the cycler by the manufacturer, there was evidence of an internal short which was identified on the transformer on the inverter board.

• 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: 8628583
• MDR Text Key: 145662639
• Report Number: 2937457-2019-01585
• 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,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• 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: 05/03/2019
• Device Age: MO
• Date Manufacturer Received: 05/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2019
• 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