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 05/04/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the screen of a patient¿s liberty select cycler went blank during their peritoneal dialysis (pd) treatment.The ok and stop keys were on, however 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.A replacement cycler was issued to the patient.It was reported that an alternate treatment option was available.Upon follow up with the patient, it was confirmed that they were able to complete treatment with no adverse events or medical intervention.The cycler was returned to the manufacturer and a replacement cycler was provided.Upon physical evaluation of the cycler by the manufacturer, it was identified that the transformer on the inverter board was shorted.

Event Description

It was reported that the screen of a patient¿s liberty select cycler went blank at the end of their peritoneal dialysis (pd) treatment.The ok and stop keys were on, however 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.A replacement cycler was issued to the patient.It was reported that an alternate treatment option was available.Upon follow up with the patient, it was confirmed that they were able to complete treatment with no adverse events or medical intervention.The cycler was returned to the manufacturer and a replacement cycler was provided.Upon physical evaluation of the cycler by the manufacturer, it was identified that the transformer on the inverter board was shorted.

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.A visual inspection of the returned cycler exterior showed no signs of physical damage.The touch screen test failed - when powering on the cycler the ¿ok, stop, and up/down arrows push buttons¿ illuminated, however the front panel touch screen remained blank.An internal inspection of the cycler found evidence of 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 touch screen became operational.The functioning inverter board was removed from the touch screen at the completion of the investigation.There were visual indications of dried fluid underneath the cassette compartment during the internal inspection.No burrs or sharps in cassette area that may have punctured a cassette membrane.The cause of the observed dried fluid could not be determined.There were no other discrepancies during the internal inspection of the returned cycler.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 a shorted transformer on the inverter board.The cycler was refurbished following the evaluation.

• 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: 8632518
• MDR Text Key: 145789526
• Report Number: 2937457-2019-01602
• 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,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• 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: 05/14/2019
• Device Age: MO
• Date Manufacturer Received: 05/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2016
• 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