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

Model Number LIBERTY SELECT CYCLER

Device Problem Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A peritoneal dialysis (pd) patient on continuous cycling peritoneal dialysis (ccpd) for renal replacement therapy (rrt) contacted technical support for assistance.During the call the patient stated that they plugged the cycler into the wall outlet and sparks came from the cycler.Upon follow up, the patient stated that they were not connected to the cycler when the spark occurred.There was no burning smell, melting, smoke or flame.The patient was able to complete peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd) in the absence of the cycler.The old cycler has been picked up and returned.The patient has received the replacement cycler and continuing with peritoneal dialysis on the new cycler without issue and without reoccurrence of the reported event.

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.A visual inspection of the returned cycler exterior showed that the rear panel was pushed in the on the right side.The power entry module was also pushed inward and damaged.The internal inspection of the cycler showed that the wires connecting the output of the power entry module and the power supply were disconnected.The hot and neutral terminals on the output of the power entry module were making contact and the terminals were shorted and fused.The internal inspection indicates that after the power entry module had been pushed inward with the hot and neutral terminals were making contact, the turning on of the cycler unit fused the terminals together.On the right side of the cycler, the rear panel had been pushed inward past the right, rear panel support block.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, 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.

• 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
• MDR Report Key: 8788708
• MDR Text Key: 150972985
• Report Number: 2937457-2019-02147
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K181108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Device Catalogue Number: RTLR180343
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Device Age: MO
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 07/15/2019
• Supplement Dates Manufacturer Received: 07/24/2019
• Supplement Dates FDA Received: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1