MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY CYCLER UL; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180111

Device Problem Sparking (2595)

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

Event Date 12/26/2017

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in progress.A supplemental medwatch report will be submitted upon completion of this activity.

Event Description

It was reported that upon attempting to power on a liberty cycler for peritoneal dialysis therapy, the back of the cycler sparked.Following the spark, the cycler would not turn on and the screen remained dark.This occurred prior to treatment and the patient had not yet connected to the cycler for therapy.A technical support representative advised the patient to discontinue use of the cycler and to notify their peritoneal dialysis registered nurse of the event.There was no reported burn damage, burn smell, or smoking from the device seen by the patient.The patient uses a designated outlet for their cycler.It was noted that the patient had recently replaced a loose power cord and this was the patient¿s first use of the cycler with the replacement power cord.There was no patient injury resulting from the reported spark.The patient was able to use manual supplies to complete their therapy.The patient has since received a replacement cycler and has been able to continue with peritoneal dialysis therapy without complications.Additional information was requested but was not available.

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An internal and external visual inspection was performed with no physical damage noted.There was no evidence of a burn smell or smoking from the device.Upon initiating a simulated treatment on the cycler, the machine turned on as designed and the treatment was completed without complication.The screen remained functional throughout the evaluation.The cycler underwent system air leak and voltage testing and was found to meet product specifications.A load cell verification test was also performed and the cycler was found to be within tolerance.An investigation 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, there were no malfunctions that could have caused or contributed to the reported event.The cycler performed as designed and an associated cause could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: LIBERTY CYCLER UL
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 7189330
• MDR Text Key: 97761422
• Report Number: 2937457-2018-00167
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• Combination Product (y/n): N
• PMA/PMN Number: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Device Age: MO
• Date Manufacturer Received: 02/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1