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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a spark was coming from a peritoneal dialysis (pd) patient¿s outlet in which the cycler was plugged into.The patient was in drain of treatment at the time of the reported event.No damage or burn mark was noted with the cycler power cord.The patient turned the cycler off and transferred the cycler to another outlet and was able to resume treatment.Upon follow up, the patient stated they were connected to the cycler and confirmed there was no harm because of this malfunction.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient indicated the cycler had never been dropped nor physically damaged and confirmed that the spark only occurred once on the day the patient contact called into technical support.The patient stated that the patient was able to complete the peritoneal dialysis treatment using the cycler after using another outlet.The patient confirmed they have had no further issues.

Manufacturer Narrative

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.

Event Description

It was reported that a spark was coming from a peritoneal dialysis (pd) patient¿s outlet in which the cycler was plugged into.The patient was in drain of treatment at the time of the reported event.No damage or burn mark was noted with the cycler power cord.The patient turned the cycler off and transferred the cycler to another outlet and was able to resume treatment.Upon follow up, the patient stated they were connected to the cycler and confirmed there was no harm because of this malfunction.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient indicated the cycler had never been dropped nor physically damaged and confirmed that the spark only occurred once on the day the patient contact called into technical support.The patient stated that the patient was able to complete the peritoneal dialysis treatment using the cycler after using another outlet.The patient confirmed they have had no further issues.

• 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: 12520461
• MDR Text Key: 272951745
• Report Number: 2937457-2021-01939
• 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: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 180343
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY CYCLER SET; DELFLEX PD FLUID; LIBERTY CYCLER SET