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

Catalog Number RTLR180343

Device Problems Smoking (1585); Sparking (2595)

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

Event Date 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in progress.A supplemental medwatch report will be submitted upon completion of this activity.

Event Description

This is a report of a peritoneal dialysis (pd) cycler that had sparks and smoke.The peritoneal dialysis registered nurse (pdrn) reported that a patient was connected to the cycler for a training treatment and the screen went blank.The pdrn stated that they smelled and saw smoke and noticed sparks.The pdrn turned off the cycler and disconnected the patient.The pdrn stated that there were no adverse events, injuries, or medical intervention required as a result of the reported event.The pdrn confirmed that the cycler was returned for evaluation.Should additional information become available, the file will be reassessed and updated accordingly.

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.The reported symptoms spark and smoke were not confirmed.The reported symptom blank screen was confirmed.An external visual inspection showed no signs of physical damage.There were visual indications of dried fluid within the cassette department.There were no burrs or sharp edges in the cassette area that may have punctured a cassette membrane.An investigation of the cycler mushroom heads verified that the surface conditions and alignments were within specification.A visual internal inspection found evidence of dried fluid under pump ¿a¿ and ¿b¿ mushroom head and within the recess of the bottom cover adjacent to the pump.The cause of the dried fluid could not be determined.Voltage check passed.The cause of the blank screen was a faulty inverter board.The inverter board fuse was measured as open.An investigation 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 or defects 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.

• 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: 7593450
• MDR Text Key: 110868018
• Report Number: 2937457-2018-01679
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/14/2018

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: Health Professional
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Device Age: MO
• Initial Date Manufacturer Received: 06/04/2018
• Initial Date FDA Received: 06/12/2018
• Supplement Dates Manufacturer Received: 06/12/2018
• Supplement Dates FDA Received: 06/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIBERTY CYCLER SET; PD SOLUTION