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 Patient Involvement (2645)

Event Date 04/19/2019

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 cycler had a spark coming from the back during set up.The cycler was plugged directly into a 3-prong outlet with no other plugs shared.At that point in time, the technical service representative advised the patient to discontinue use of the cycler.The patient was advised to follow up with their peritoneal dialysis registered nurse.A new cycler was issued to the patient.Upon follow up, the patient confirmed that there was no injury or adverse event as a result of the sparking cycler.The patient was able to complete treatment using manuals.The new cycler was received and the old cycler was returned to the manufacturer for evaluation.

Manufacturer Narrative

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.The cycler underwent and passed a system air leak test, valve actuation test, load cell verification check, hipot test, and safety analyzer test.An as received simulated treatment with reduced dwell times was performed and completed without any failures or problems.There were no visual discrepancies encountered during the internal inspection.There were no loose electrical connections and the cycler was properly grounded.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: 8566260
• MDR Text Key: 143605415
• Report Number: 2937457-2019-01264
• 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: 05/21/2019

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 Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Device Age: MO
• Initial Date Manufacturer Received: 04/20/2019
• Initial Date FDA Received: 04/30/2019
• Supplement Dates Manufacturer Received: 05/20/2019
• Supplement Dates FDA Received: 05/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1