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 02/10/2022

Event Type  malfunction  

Event Description

It was reported that a peritoneal dialysis (pd) patient returned home from a trip where the cycler was transported on an airline in a travel case.The patient plugged the cycler into an electrical outlet at home and a spark occurred at the power cord and electrical outlet.The patient unplugged the power cord from electrical outlet and then from the back of the cycler.The patient then plugged the cord back into the electrical outlet, then plugged the other end into the rear of the cycler and a spark occurred at the cycler electrical socket.The cycler was not on at any time when the sparks occurred.The patient then disconnected the power cord from the cycler and electrical outlet.Technical support assisted the patient with plugging a lamp into the same electrical outlet, and a spark did not occur.Technical support advised the patient to always plug the power cord into the cycler first then an electrical outlet.At that point in time, the technical support representative advised the patient to discontinue use of the cycler and to notify their peritoneal dialysis registered nurse (pdrn) of the event.A replacement cycler was issued to the patient.It was reported that an alternate treatment option was available.Upon follow up, the patient confirmed the reported event.The patient stated that there was no burning smell, melting, smoke, or flame.The patient confirmed that there was no damage to the outlet itself and that the sparking was noticed during setup for treatment.The patient stated that the power cord was the original fresenius part on the machine, however did not notice any other damaged component associated with the sparking.The patient stated that the cycler has been replaced and is performing as intended without reoccurrence of the reported event.The patient confirmed not being connected to the cycler at the time of the incident and there was no harm to any individuals because of this malfunction.Additionally, the patient confirmed that the old cycler is available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

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

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 returned home from a trip where the cycler was transported on an airline in a travel case.The patient plugged the cycler into an electrical outlet at home and a spark occurred at the power cord and electrical outlet.The patient unplugged the power cord from electrical outlet and then from the back of the cycler.The patient then plugged the cord back into the electrical outlet, then plugged the other end into the rear of the cycler and a spark occurred at the cycler electrical socket.The cycler was not on at any time when the sparks occurred.The patient then disconnected the power cord from the cycler and electrical outlet.Technical support assisted the patient with plugging a lamp into the same electrical outlet, and a spark did not occur.Technical support advised the patient to always plug the power cord into the cycler first then an electrical outlet.At that point in time, the technical support representative advised the patient to discontinue use of the cycler and to notify their peritoneal dialysis registered nurse (pdrn) of the event.A replacement cycler was issued to the patient.It was reported that an alternate treatment option was available.Upon follow up, the patient confirmed the reported event.The patient stated that there was no burning smell, melting, smoke, or flame.The patient confirmed that there was no damage to the outlet itself and that the sparking was noticed during setup for treatment.The patient stated that the power cord was the original fresenius part on the machine, however did not notice any other damaged component associated with the sparking.The patient stated that the cycler has been replaced and is performing as intended without reoccurrence of the reported event.The patient confirmed not being connected to the cycler at the time of the incident and there was no harm to any individuals because of this malfunction.Additionally, the patient confirmed that the old cycler is available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.A visual inspection of the returned cycler exterior showed the power entry module and front panel bezel were damaged.There were visual indications of dried fluid within the cassette compartment 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.The power-on verification failed.The power cord was inserted to the power entry module and the power switch set to on, but the cycler did not power on.An internal visual inspection of the returned cycler was performed.There were visual indications of dried fluid on the bottom cover under the pump and on the baseplate under the pump.The cause of the observed dried fluid could not be determined.The spade connectors on the power entry module were disconnected and found to be the cause of the power-on verification test failure.The spade connectors were reconnected and the cycler became operable.The catch-post hipot, patient hipot, and current leakage tests passed.A simulated treatment was performed and passed with no further alarms or issues.No fluid leaks in the test cassette during the treatment test.The system air leak, valve actuation test, patient pressure sensor calibration check, voltage calibration checks, and mushroom head checks passed.No evidence of a "spark" found during troubleshooting.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.The investigation into the cause of the reported problem was not able to be confirmed.

Event Description

It was reported that a peritoneal dialysis (pd) patient returned home from a trip where the cycler was transported on an airline in a travel case.The patient plugged the cycler into an electrical outlet at home and a spark occurred at the power cord and electrical outlet.The patient unplugged the power cord from electrical outlet and then from the back of the cycler.The patient then plugged the cord back into the electrical outlet, then plugged the other end into the rear of the cycler and a spark occurred at the cycler electrical socket.The cycler was not on at any time when the sparks occurred.The patient then disconnected the power cord from the cycler and electrical outlet.Technical support assisted the patient with plugging a lamp into the same electrical outlet, and a spark did not occur.Technical support advised the patient to always plug the power cord into the cycler first then an electrical outlet.At that point in time, the technical support representative advised the patient to discontinue use of the cycler and to notify their peritoneal dialysis registered nurse (pdrn) of the event.A replacement cycler was issued to the patient.It was reported that an alternate treatment option was available.Upon follow up, the patient confirmed the reported event.The patient stated that there was no burning smell, melting, smoke, or flame.The patient confirmed that there was no damage to the outlet itself and that the sparking was noticed during setup for treatment.The patient stated that the power cord was the original fresenius part on the machine, however did not notice any other damaged component associated with the sparking.The patient stated that the cycler has been replaced and is performing as intended without reoccurrence of the reported event.The patient confirmed not being connected to the cycler at the time of the incident and there was no harm to any individuals because of this malfunction.Additionally, the patient confirmed that the old cycler is 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
• 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: 13524303
• MDR Text Key: 285625590
• Report Number: 2937457-2022-00236
• 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
• Report Date: 03/03/2022

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: 02/22/2022
• Device Age: MO
• Initial Date Manufacturer Received: 02/10/2022
• Initial Date FDA Received: 02/14/2022
• Supplement Dates Manufacturer Received: 03/01/2022
• Supplement Dates FDA Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2011
• 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