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 08/14/2021

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 cycler.The patient contact reported the screen went black during power up and remained blank.The ok and stop keys made sounds when pressed and lit up but the screen remained blank.There were also sparks from the back of the cycler.No smoke or burning smell was noted.The patient was not connected during the incident.At that point in time, the technical support representative advised the patient to discontinue use of the cycler.It was reported that an alternate treatment was available.A replacement cycler was issued to the patient.Upon follow up, the pdrn confirmed the patient was not connected to the cycler and powered up the cycler when the reported event occurred.The pdrn confirmed that 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 pdrn 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 pdrn stated that no burning smell melting or flame was noted.The pdrn stated that the patient was able to complete the peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd) in the absence of the cycler.The pdrn confirmed the patient received a replacement cycler and has had no further issues.The cycler has been returned to the manufacturer for physical evaluation.

Event Description

It was reported that a spark was coming from a peritoneal dialysis (pd) patient¿s cycler.The patient contact reported the screen went black during power up and remained blank.The ok and stop keys made sounds when pressed and lit up but the screen remained blank.There were also sparks from the back of the cycler.No smoke or burning smell was noted.The patient was not connected during the incident.At that point in time, the technical support representative advised the patient to discontinue use of the cycler.It was reported that an alternate treatment was available.A replacement cycler was issued to the patient.Upon follow up, the pdrn confirmed the patient was not connected to the cycler and powered up the cycler when the reported event occurred.The pdrn confirmed that 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 pdrn 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 pdrn stated that no burning smell melting or flame was noted.The pdrn stated that the patient was able to complete the peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd) in the absence of the cycler.The pdrn confirmed the patient received a replacement cycler and has had had no further issues.The cycler has been returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Additional information: d9.H3 plant investigation: actual device returned to the manufacturer.Visual inspection of returned cycler exterior showed no signs of physical damage.Visual indications of dried fluid noted within cassette compartment on the top cover.No visual indications of particulates within the cassette area.No burrs or sharp edges in cassette area that may have punctured a cassette membrane.No evidence of physical damage or scorch marks on power cord port on back of the power entry module.Cycler underwent and passed a catch-post hipot test, patient hipot test, current leakage test, system air leak test, valve actuation test, patient pressure sensor calibration check, voltage calibration check and mushroom head checks.A post-accelerated stress test simulated treatment was performed and passed with no alarms or issues.Touch screen test failed due to a dim front panel display.The display was still operational and functional.The display was dim due to an internal short present on transformer (t1) of the ¿inverter board¿.An internal visual inspection of the returned cycler was performed.There were visual indications of dried fluid on the bottom cover under the pump, on the inside of the rear panel, and behind mushroom heads a & b.The cause of observed dried fluid could not be determined.A loose ground screw connected to the power entry module¿s j1 cable was found during the internal inspection.No evidence of scorch marks or physical damage found on the j1 ground cable.All electrical testing passed, no evidence of an electrical spark was reproduced during the investigation.Review of the device manufacturing records was conducted by the manufacturer.No deviations or non-conformances during manufacturing process.Device history record (dhr) review performed and verified results of in-progress and final quality control (qc) testing met all requirements.The reported issue was confirmed.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: 12334038
• MDR Text Key: 267045133
• Report Number: 2937457-2021-01714
• 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: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Device Age: MO
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1