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

Model Number 180343

Device Problem Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 09/22/2020

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¿s contact called fresenius technical support (ts) to report an issue with the cycler's power cord that was experienced during treatment setup.The previous day, the contact had called ts to report that the screen of the patient¿s liberty select cycler went blank towards the end of their treatment.They were able to rectify the screen issue during that call and the patient successfully completed their treatment.The following day, the contact called back during setup because the blank screen issue had returned.They were unable to get the screen to turn back on.While troubleshooting, a spark was seen coming from the power cord-to-cycler connection point.The spark occurred while they were in the process of unplugging/reseating the power cord to ensure a proper connection was established.There was no evidence of a burning smell, smoking, charring, or melting.After seeing the spark, the cycler was unplugged and use of the machine was discontinued.A replacement cycler was issued to the patient.It was confirmed that the patient completed their treatment by performing a manual exchange, and they continued to do so until the replacement cycler was received.At the time of follow-up, the patient was continuing their pd therapy on the replacement cycler with no further issues.The power cord that sparked was returned to the manufacturer for evaluation, along with the old cycler.

Manufacturer Narrative

Additional information: h3 plant investigation: no parts were returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Manufacturer Narrative

Additional information: d10, h3 plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed on the cycler with no physical damage noted.A pre-accelerated stress test (ast) simulated treatment was performed on the cycler and passed.A voltage check was also performed and passed.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; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 10661594
• MDR Text Key: 211094541
• Report Number: 2937457-2020-01834
• 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,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 180343
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Device Age: MO
• Date Manufacturer Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1