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 Patient Involvement (2645)

Event Date 06/04/2019

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.The reported symptom noisy was not confirmed.The reported fluid temperature out of range alarm was confirmed.The system air leak test passed.The teach pump test passed.The heater calibration test failed.Further investigation led to find a short on f1 of the ac distribution board which was causing the heater tray unable to warm up.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 a short on the distribution board.The cycler was refurbished following the evaluation.

Event Description

It was reported that the patient¿s liberty select cycler was noisy and receiving a fluid temperature out of range alarm during step 7 of set up.The patient stated that the loud cracking noise was occurring during the beginning steps of set up.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, manuals was available.Upon follow up, the peritoneal dialysis registered nurse (pdrn) stated that the patient completed treatment manually.There were no adverse events or medical intervention required as a result of the reported event.The cycler was returned to the manufacturer and a replacement cycler was provided and received.Upon physical evaluation of the cycler by the manufacturer, it was identified that there was a short on the ac distribution 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: 8816800
• MDR Text Key: 151885948
• Report Number: 2937457-2019-02279
• 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,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• 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: 06/14/2019
• Device Age: MO
• Date Manufacturer Received: 07/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2014
• 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