MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY (NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Model Number LIBERTY SELECT CYCLER ASSY (NON-VALUATED)

Device Problem Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/20/2018

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is being conducted by the manufacturer of the device, a supplement mdr will be submitted upon receipt of the investigation results.

Event Description

It was reported a patients integron liberty select 4g (b)(6) modem a component of the liberty select cycler was smoking and making a strange noise.Additionally, it was reported the patient¿s son touched the modem and was shocked upon contact, no medical intervention was required.Upon follow up, the patient's peritoneal dialysis registered nurse (pdrn) confirmed the modem was smoking and was making a sizzling noise.The pdrn stated the patient did report the son was shocked by the modem, and no medical intervention was required.Additional details of the shock were solicited, but unavailable.The pdrn confirmed the patient did not experience any adverse events or injuries and no medical intervention was required as a result of the event.The pdrn stated the patient is trained to perform continuous ambulatory peritoneal dialysis and was able to complete treatment using manual exchanges on the night of the event.The modem has been removed from the cycler and is scheduled to be picked up and returned to the manufacturing plant for investigation.The patient has resumed treatment on the cycler.

Manufacturer Narrative

Plant investigation: the actual modem (lot #19716843) was returned to the manufacturer for failure analysis.The modem was taken through the returns troubleshooting script and found no issues with functionality.It was able to register to a tower and ping an external site.There were not any markings, stains, or other visual damage on the modem exterior or sim, nor was there any noticeable smell that would indicate smoke or heat damage.The modem was plugged in and powered on for several days as part of additional testing.Throughout this extended powered test, the modem remained cool to the touch.The device did not cause a shock to the operators handling the equipment.Upon completion of the evaluation, there were no malfunctions that could have caused or contributed to the reported event.The modem performed as designed and an associated cause could not be determined.

Event Description

• 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; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7859364
• MDR Text Key: 119654047
• Report Number: 1225714-2018-00006
• 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: K171652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LIBERTY SELECT CYCLER ASSY (NON-VALUATED)
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 10/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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 SOLUTION; LIBERTY CYCLER SET