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 05/05/2020

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 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 on transformer (t1) of the inverter board.The inverter board is located on the rear of the front panel assembly.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.The out-of-box failure was verified as zero completed treatments were found in the patient's treatment history.Upon completion of the evaluation, the reported issue was confirmed and the cause was determined to be an internal short on the transformer of the inverter board.The cycler was refurbished following the evaluation.

Event Description

A peritoneal dialysis (pd) patient contact called fresenius technical support (ts) to report the liberty select cycler screen went blank during step 7 of set-up.The ok and stop keys were on, however the screen remained blank.The cycler was rebooted but the screen remained blank.At that point in time, the patient contact was advised to discontinue use of cycler and to notify the patient's peritoneal dialysis registered nurse (pdrn).A replacement cycler was issued to the patient.This was reported to be an out-of-box failure.It was reported that an alternate treatment option was available.There was no patient harm or adverse event reported.Additional information was requested, however, to date not provided.The cycler was returned to the manufacturer.Upon physical evaluation of the cycler by the manufacturer, an internal short was identified on the transformer of the inverter board.

• 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: 10087881
• MDR Text Key: 192016768
• Report Number: 2937457-2020-00929
• 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: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• 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: 05/11/2020
• Device Age: MO
• Date Manufacturer Received: 05/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2010
• 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