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 peritoneal dialysis registered nurse (pdrn) contacted fresenius technical support (ts) to report sparking that was seen coming from the rear of a liberty select cycler, at its power cord port.The cycler was in step 1 of setup when it unexpectedly powered down.The power cord connection was checked and confirmed to be securely connected on both ends.The pdrn restarted the cycler, and during the setup phase it powered off again.This time, the pdrn observed sparks coming from the back of the cycler where the power cord connects to the device.The pdrn unplugged the cycler and set the patient up for a manual exchange.The cycler was replaced by ts, and upon follow-up it was confirmed that the replacement had arrived.The noted sparks did not result in any patient or bystander harm, and it was confirmed the patient completed their treatment by performing a manual exchange.There were no signs of a burning smell, smoke, or flames.In addition, the pdrn confirmed that no charring or blackening was left behind on the cord or cycler.Reportedly, there were no issues with the outlet itself.The outlet had been used many times before the event without any problems, and they have continued to use it without reoccurrence.The pdrn confirmed there was no fluid that spilled onto the cycler which could have triggered the sparking.It was unknown what the cause may have been.The cycler was available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Additional information: d9, h3 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.A post-accelerated stress test (ast) simulated treatment was performed on the cycler and completed without any failures or problems.The cycler underwent and passed a voltage test, a catch post hi pot test, a patient hi pot test, and a safety analyzer test.No discrepancies were encountered during the internal visual inspection of the cycler.There were no indications of sparking occurring or any visual evidence of any heat damage on or within the cycler.Furthermore, the cycler did not power off or on by itself during the testing.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 peritoneal dialysis registered nurse (pdrn) contacted fresenius technical support (ts) to report sparking that was seen coming from the rear of a liberty select cycler, at its power cord port.The cycler was in step 1 of setup when it unexpectedly powered down.The power cord connection was checked and confirmed to be securely connected on both ends.The pdrn restarted the cycler, and during the setup phase it powered off again.This time, the pdrn observed sparks coming from the back of the cycler where the power cord connects to the device.The pdrn unplugged the cycler and set the patient up for a manual exchange.The cycler was replaced by ts, and upon follow-up it was confirmed that the replacement had arrived.The noted sparks did not result in any patient or bystander harm, and it was confirmed the patient completed their treatment by performing a manual exchange.There were no signs of a burning smell, smoke, or flames.In addition, the pdrn confirmed that no charring or blackening was left behind on the cord or cycler.Reportedly, there were no issues with the outlet itself.The outlet had been used many times before the event without any problems, and they have continued to use it without reoccurrence.The pdrn confirmed there was no fluid that spilled onto the cycler which could have triggered the sparking.It was unknown what the cause may have been.The cycler was available to be 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: 12363252
• MDR Text Key: 268051071
• Report Number: 2937457-2021-01773
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/11/2021

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 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
• Initial Date Manufacturer Received: 08/05/2021
• Initial Date FDA Received: 08/24/2021
• Supplement Dates Manufacturer Received: 08/25/2021
• Supplement Dates FDA Received: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1