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 08/05/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A nurse reported that the liberty select cycler had a loose power cord, powers down, and a spark occurred during an unknown phase of the peritoneal dialysis (pd) patient¿s treatment.The cyclers power cord was loose where it connects to the back of the cycler.The power cord was not securely plugged in, and the power switch was in the on position.The nurse reported that the spark issue occurred immediately after the power cord became loose from the cycler.The spark came out from the power cord port at the back of the cycler.The nurse reported that the treatment was cancelled, and the patient resumed on another cycler.The nurse was advised to discontinue the use of their cycler.A new cycler was issued to the patient.Upon follow up, the pdrn stated the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed.The pdrn stated that there was no patient involvement as the issue occurred during setup.The pdrn stated that the patient information is unknown.The pdrn stated that the patient did witness a spark coming from the plug of the cycler.The pdrn stated the patient did not observe any burning smell, smoke, flame, or arcing.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 which is working well and is continuing peritoneal dialysis therapy with no further issues.The cycler was returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Additional information: d9, h3 plant investigation: external visual inspection was performed on the cycler with no physical damage noted.No evidence of physical damage or scorch marks on the power cord port on the back of the power entry module.Pre-accelerated stress test 15-minutes 1000ml simulated treatment was performed and passed with no further alarms or issues.The cycler underwent and passed a system air leak test, valve actuation test, voltage calibration check, catch-post hipot test, patient hipot test, current leakage, and patient sensor calibration check.An internal visual inspection of the returned cycler was performed and found no discrepancies.All electrical testing passed, no evidence an electrical spark was reproduced during the investigation.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.Investigation: the actual device was returned to the manufacturer for physical evaluation.

Event Description

A nurse reported that the liberty select cycler had a loose power cord, powers down, and a spark occurred during an unknown phase of the peritoneal dialysis (pd) patient¿s treatment.The cyclers power cord was loose where it connects to the back of the cycler.The power cord was not securely plugged in, and the power switch was in the on position.The nurse reported that the spark issue occurred immediately after the power cord became loose from the cycler.The spark came out from the power cord port at the back of the cycler.The nurse reported that the treatment was cancelled, and the patient resumed on another cycler.The nurse was advised to discontinue the use of their cycler.A new cycler was issued to the patient.Upon follow up, the pdrn stated the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed.The pdrn stated that there was no patient involvement as the issue occurred during setup.The pdrn stated that the patient information is unknown.The pdrn stated that the patient did witness a spark coming from the plug of the cycler.The pdrn stated the patient did not observe any burning smell, smoke, flame, or arcing.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 which is working well and is continuing peritoneal dialysis therapy with no further issues.The cycler was returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Correction: a1, b7, h10 plant investigation: an external visual inspection was performed on the cycler with no physical damage noted.No evidence of physical damage or scorch marks on the power cord port on the back of the power entry module.Pre-accelerated stress test 15-minutes 1000ml simulated treatment was performed and passed with no further alarms or issues.The cycler underwent and passed a system air leak test, valve actuation test, voltage calibration check, catch-post hipot test, patient hipot test, current leakage, and patient sensor calibration check.An internal visual inspection of the returned cycler was performed and found no discrepancies.All electrical testing passed, no evidence an electrical spark was reproduced during the investigation.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.

Event Description

A nurse reported that the liberty select cycler had a loose power cord, powers down, and a spark occurred during an unknown phase of the peritoneal dialysis (pd) patient¿s treatment.The cyclers power cord was loose where it connects to the back of the cycler.The power cord was not securely plugged in, and the power switch was in the on position.The nurse reported that the spark issue occurred immediately after the power cord became loose from the cycler.The spark came out from the power cord port at the back of the cycler.The nurse reported that the treatment was cancelled, and the patient resumed on another cycler.The nurse was advised to discontinue the use of their cycler.A new cycler was issued to the patient.Upon follow up, the pdrn stated the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed.The pdrn stated that there was no patient involvement as the issue occurred during setup.The pdrn stated that the patient information is unknown.The pdrn stated that the patient did witness a spark coming from the plug of the cycler.The pdrn stated the patient did not observe any burning smell, smoke, flame, or arcing.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 which is working well and is continuing peritoneal dialysis therapy with no further issues.The cycler was returned to the manufacturer for physical 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: 12363251
• MDR Text Key: 268050852
• Report Number: 2937457-2021-01772
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• 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: 08/21/2021
• Device Age: MO
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; LIBERTY CYCLER SET