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

Catalog Number RTLR180343

Device Problem Sparking (2595)

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

Event Date 11/17/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a peritoneal dialysis (pd) patient observed sparks from the power cord connection on their liberty select cycler.The patient indicated that they had accidentally knocked over the cycler during dwell 1 of 3 and noticed the sparks when they were reconnecting the power cord.The technical support representative advised to discontinue use of the cycler and to notify their peritoneal dialysis registered nurse (pdrn) of the event.A replacement cycler was issued to the patient.Upon follow up, the patient indicated the sparks were coming directly from the port where the power cord is connected to the cycler.The power cord is connected to a 3 prong outlet.There was no damage to the immediate environment as a result of the sparking.The patient reported that treatment was completed with cycler and he experienced no further issues.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient has received a new cycler.The reported cycler has been returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.External visual inspection of the returned cycler showed no signs of physical damage or any other discrepancies.An as received simulated treatment was performed and completed without failures.There were no indications of sparks observed during the treatment test.The cycler did not power down during the treatment test.The cycler underwent and passed a system air leak test, valve actuation test, catch post hipot test, current leakage test, and a voltage check.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, the reported issue was unconfirmed and the cause could not be determined.The cycler was refurbished following the evaluation.

• 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: 9397664
• MDR Text Key: 170701338
• Report Number: 2937457-2019-03507
• 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: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Device Age: MO
• Date Manufacturer Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Age: 81 YR