MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY SELECT CYCLER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180343

Device Problem Overheating of Device (1437)

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

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

A supplemental mdr will be submitted upon device evaluation.

Event Description

A peritoneal dialysis patient reported he had left the cycler on.He was not connected at the time.When his wife came home she smelled something hot and by checking around they found the smell was coming from the cycler.What looked like glue or epoxy was coming from the top of the display area and the display and surrounding was very warm to touch.The display remained lit.He turned the cycler off and unplugged it before calling tech support.The cycler was replaced.During follow up the patient reported there was no adverse event.

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed with no physical damage noted.Upon internal inspection, there was no presence of visible liquid or evidence of past fluid within cycler.A simulated therapy was initiated and completed on the cycler without complication.The cycler underwent system air leak and valve actuation testing and was found to meet product specifications.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.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Follow up #1 correction- additional information: device available for evaluation, device evaluated by mfr.

• Brand Name: LIBERTY SELECT CYCLER
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 7360008
• MDR Text Key: 103133474
• Report Number: 2937457-2018-00845
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K171652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2018

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: 03/26/2018
• Device Age: MO
• Initial Date Manufacturer Received: 03/01/2018
• Initial Date FDA Received: 03/21/2018
• Supplement Dates Manufacturer Received: 04/12/2018; 04/12/2018
• Supplement Dates FDA Received: 04/12/2018; 04/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIBERTY CYCLER SET; PD FLUID