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

Model Number 180343

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

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

Event Date 10/07/2021

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 peritoneal dialysis (pd) patient saw sparks coming from the back of the cycler and smelled burning after inserting the cassette during step 1 of setup.Technical support advised the patient to turn off the cycler and contact the pd nurse.The patient was advise to discontinue the use of the cycler.A replacement cycler was issued to the patient.It was reported that an alternate treatment option was not available.Upon follow up, the patient confirmed the reported product complaint.The patient stated that the cycler would not accept the cassette when inserted twice and during the third time sparks were seen inside the back of the cycler and inside the plug which had a burning smell.No smoke was seen and the patient confirmed that there was no damage observed on any other components, or any other additional issues, associated with the sparks and burning smell.The patient was not in treatment at the time of the incident and there was no harm to the patient because of this malfunction.The patient has received the replacement cycler and is continuing with peritoneal dialysis on the new cycler without issue and without reoccurrence of the reported event, however, the old cycler is available to be picked up and returned.

Manufacturer Narrative

Correction: problem code 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 saw sparks coming from the back of the cycler and smelled burning after inserting the cassette during step 1 of setup.Technical support advised the patient to turn off the cycler and contact the pd nurse.The patient was advise to discontinue the use of the cycler.A replacement cycler was issued to the patient.It was reported that an alternate treatment option was not available.Upon follow up, the patient confirmed the reported product complaint.The patient stated that the cycler would not accept the cassette when inserted twice and during the third time sparks were seen inside the back of the cycler and inside the plug which had a burning smell.No smoke was seen and the patient confirmed that there was no damage observed on any other components, or any other additional issues, associated with the sparks and burning smell.The patient was not in treatment at the time of the incident and there was no harm to the patient because of this malfunction.The patient has received the replacement cycler and is continuing with peritoneal dialysis on the new cycler without issue and without reoccurrence of the reported event, however, the old cycler is available to be picked up and returned.

Event Description

It was reported that a peritoneal dialysis (pd) patient saw sparks coming from the back of the cycler and smelled burning after inserting the cassette during step 1 of setup.Technical support advised the patient to turn off the cycler and contact the pd nurse.The patient was advise to discontinue the use of the cycler.A replacement cycler was issued to the patient.It was reported that an alternate treatment option was not available.Upon follow up, the patient confirmed the reported product complaint.The patient stated that the cycler would not accept the cassette when inserted twice and during the third time sparks were seen inside the back of the cycler and inside the plug which had a burning smell.No smoke was seen and the patient confirmed that there was no damage observed on any other components, or any other additional issues, associated with the sparks and burning smell.The patient was not in treatment at the time of the incident and there was no harm to the patient because of this malfunction.The patient has received the replacement cycler and is continuing with peritoneal dialysis on the new cycler without issue and without reoccurrence of the reported event, however, the old cycler is available to be picked up and returned.

Manufacturer Narrative

Additional information; d9, g1, h3 plant investigation: the actual device was returned to the manufacturer for physical evaluation.An exterior visual inspection of the returned cycler showed no signs of physical damage.There were visual indications of dried fluid within the cassette compartment on the pump door, on the safety clamp, and on the top cover.There were no visual indications of particulates within the cassette area.There were no burrs or sharp edges in cassette area that may have punctured a cassette membrane.No evidence of physical damage or scorch marks on the power cord port on the back of the power entry module.A simulated treatment was performed and passed with no further alarms or issues.Multiple system tests were performed and all passed.Upon power up, the cycler touch screen test failed.When powering on the cycler, the ok, stop and up/down arrow push buttons illuminated, however the front panel touch screen remained dim.It was identified that the cause for the dim screen was due to an internal short present transformer (t1) on the inverter board.A known good inverter board was installed and the display became fully operational.An internal visual inspection of the returned cycler encountered visual indications of dried fluid on the baseplate under the pump assembly, on the bottom cover under the pump, and on the bottom cover behind the front panel.The cause of the observed dried fluid could not be determined.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 reported issue was confirmed and the cause was determined to be an internal short on transformer on the inverter board.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
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 12616220
• MDR Text Key: 275919944
• Report Number: 2937457-2021-02041
• 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: 11/26/2021

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: Lay User/Patient
• Device Model Number: 180343
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Device Age: MO
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 10/12/2021
• Supplement Dates Manufacturer Received: 11/09/2021; 11/23/2021
• Supplement Dates FDA Received: 11/09/2021; 11/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2013
• 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