MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180343

Device Problems Thermal Decomposition of Device (1071); Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2023

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 peritoneal dialysis (pd) patient¿s caretaker encountered a cycler that had sparks shoot out of the external electrical port while the patient was in an active treatment.Upon follow up, the caretaker reported that there were not any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The caretaker said the electrical port was loose and wiggled when trying to plug the electrical cord into the port.The patient received a new cycler and is continuing peritoneal dialysis therapy with no further issues.The cycler is available for return for physical evaluation by the manufacturer.

Manufacturer Narrative

Correction: g.4., h.6., h.10 plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed on the cycler.A visual inspection of the returned cycler exterior showed damaged front panel bezel.There were visual indications of dried fluid within the cassette compartment.There were no burrs or sharp edges in cassette area that may have punctured a cassette membrane.Touch screen test failed - when powering on the cycler the ¿ok, stop, and up/down arrows push buttons¿ illuminated, however the front panel display remained dim.An internal inspection of the cycler found transformer (t1) on the ¿inverter board¿ to have an internal short.The inverter board is located on the rear of the front panel assembly.A known good inverter board was installed and the display became operational.Removed functioning inverter board from the front panel at the completion of the investigation.There were visual indications of dried fluid under the pump assembly on the bottom cover.The cause of the observed dried fluid could not be determined.Checked power cord connection.Power cord is secured.Voltage passed.Touch screen passed.Hi pot passed.Patient hi pot passed.Safety analyzer passed.Post-ast 2hours 15mins 8500ml simulated treatment was performed without any failures or problems.Mushroom head check passed.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, the sparks coming from the rear terminal on cycler could not be duplicated.However, thermal decomposition and display brightness problem were encountered, and the cause was traced to component failure.

Event Description

It was reported that a peritoneal dialysis (pd) patient¿s caretaker encountered a cycler that had sparks shoot out of the external electrical port while the patient was in an active treatment.Upon follow up, the caretaker reported that there were not any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The caretaker said the electrical port was loose and wiggled when trying to plug the electrical cord into the port.The patient received a new cycler and is continuing peritoneal dialysis therapy with no further issues.The cycler is available for return for physical evaluation by the manufacturer.

Manufacturer Narrative

Additional information: d.9., h.3.Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed on the cycler.A visual inspection of the returned cycler exterior showed damaged front panel bezel.There were visual indications of dried fluid within the cassette compartment.There were no burrs or sharp edges in cassette area that may have punctured a cassette membrane.Touch screen test failed - when powering on the cycler the ¿ok, stop, and up/down arrows push buttons¿ illuminated, however the front panel display remained dim.An internal inspection of the cycler found transformer (t1) on the ¿inverter board¿ to have an internal short.The inverter board is located on the rear of the front panel assembly.A known good inverter board was installed and the display became operational.Removed functioning inverter board from the front panel at the completion of the investigation.There were visual indications of dried fluid under the pump assembly on the bottom cover.The cause of the observed dried fluid could not be determined.Checked power cord connection.Power cord is secured.Voltage passed.Touch screen passed.Hi pot passed.Patient hi pot passed.Safety analyzer passed.Post-ast 2hours 15mins 8500ml simulated treatment was performed without any failures or problems.Mushroom head check passed.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.An associated cause could not be determined.

Event Description

It was reported that a peritoneal dialysis (pd) patient¿s caretaker encountered a cycler that had sparks shoot out of the external electrical port while the patient was in an active treatment.Upon follow up, the caretaker reported that there were not any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The caretaker said the electrical port was loose and wiggled when trying to plug the electrical cord into the port.The patient received a new cycler and is continuing peritoneal dialysis therapy with no further issues.The cycler is available for return for physical evaluation by the manufacturer.

• 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
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 18187770
• MDR Text Key: 328763160
• Report Number: 0002937457-2023-01757
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• 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
• Device Age: MO
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID.; DELFLEX PD FLUID.; DELFLEX PD FLUID.; LIBERTY CYCLER SET.; LIBERTY CYCLER SET.; LIBERTY CYCLER SET.
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 118 KG