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 05/07/2020

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.The cycler touch screen test failed.When powering on the cycler, the ok, stop and up/down arrow push buttons did not illuminate, 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.A known good inverter board was installed and the display became fully operational.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-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 on transformer on the inverter board.The cycler was refurbished following the evaluation.

Event Description

It was reported that the screen of a liberty select cycler went blank during step 8 of the patient's peritoneal dialysis (pd) end treatment.The peritoneal dialysis registered nurse (pdrn) reported that a burning smell was noticed after the blank screen occurred.The ok and stop keys and touch screen were pressed, however the screen remained blank.The ok and stop keys made sounds when pressed.The pdrn stated that the burning smell was coming from the back of the cycler near the power cord.The power cord was connected directly into a shared 3-prong outlet, which was shared by a recliner chair.At that point in time, the technical support representative advised the pdrn to discontinue use of the cycler.A replacement cycler was issued to the patient.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 complete treatment on another cycler.The cycler was returned to the manufacturer and a replacement cycler was provided and received.The pdrn stated that they did not see any fire, flames, smoke, or sparks coming from the cycler.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; 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: 10084103
• MDR Text Key: 191870769
• Report Number: 2937457-2020-00910
• 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: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 180343
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2020
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 05/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2012
• 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