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 05/07/2019

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.Although there were visual indications of dried fluid within the cassette compartment, there were no burrs or sharp edges in cassette area that may have punctured a cassette membrane.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.It was identified that the cause for the 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.The mushroom head check passed.The cycler tested positive for glucose.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformance 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

A contact of a peritoneal dialysis (pd) patient called fresenius technical support to report the liberty cycler has a display brightness problem during step 10 of the treatment end screens.Patient contact stated that the power cord is loose from the back of the cycler and has to tape it to keep it in place.Patient contact stated that the screen is also dim and hard to see.Brightness was set to 9, was changed to 10, but after adjusting the power cord screen became dim again.Cycler is plugged directly into a three prong wall outlet, and shared with a mini-refrigerator.The fresenius technical support representative advised patient's contact that it is best to have cycler on its own outlet.The fresenius technical support representative issued a replacement cycler and advised the patient to discontinue using the machine.There was no patient harm or adverse event, and no medical intervention was required.Alternate treatment option is not available.Upon follow up, it was confirmed that no patient adverse effects were experienced and no medical intervention was required.The patient did not complete the treatment that day but resumed treatments on the new cycler with no further issue.The cycler was returned and 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; 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: 8645546
• MDR Text Key: 146221005
• Report Number: 2937457-2019-01678
• 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: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2019
• 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: 05/16/2019
• Device Age: MO
• Date Manufacturer Received: 05/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2019
• 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