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 01/26/2022

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 sparks were coming from a peritoneal dialysis (pd) patient¿s cycler.The patient reported the power cord was not securely plugged in and sparks were observed from the cycler when the power cord was secured to the cycler.The patient was unable to check the connection going to the wall outlet and there were no lights on the cycler buttons or the iq drive.The patient was not connected during the incident.At that point in time, the technical support representative advised the patient to discontinue use of the cycler.It was reported that an alternate treatment was not available as the patient did not remember how to use the manual supplies.A replacement cycler was issued to the patient.Upon follow up, the pdrn confirmed there was no patient involvement as the patient was not connected to the cycler.The pdrn confirmed that there was no harm because of this malfunction.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The pdrn indicated the cycler had never been dropped nor physically damaged and confirmed that the spark only occurred once on the day the patient contact called into technical support.The pdrn stated that no burning smell melting or flame was noted.The pdrn stated that the patient missed several treatments in the absence of the cycler issue and did not immediately report the event or missed treatments.The pdrn confirmed the patient received a replacement cycler and has had no further issues.The cycler has been 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 no signs of physical damage.There were visual indications of dried fluid within the cassette compartment.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.A post-accelerated stress test (ast) was performed on the cycler and passed.The cycler underwent and passed a voltage test, patient hipot test, hipot test and safety analyzer test.An investigation of the cycler mushroom heads verified that the surface conditions and alignments were within specification.An internal visual inspection of the returned cycler encountered no discrepancies.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

It was reported that sparks were coming from a peritoneal dialysis (pd) patient¿s cycler.The patient reported the power cord was not securely plugged in and sparks were observed from the cycler when the power cord was secured to the cycler.The patient was unable to check the connection going to the wall outlet and there were no lights on the cycler buttons or the iq drive.The patient was not connected during the incident.At that point in time, the technical support representative advised the patient to discontinue use of the cycler.It was reported that an alternate treatment was not available as the patient did not remember how to use the manual supplies.A replacement cycler was issued to the patient.Upon follow up, the pdrn confirmed there was no patient involvement as the patient was not connected to the cycler.The pdrn confirmed that there was no harm because of this malfunction.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The pdrn indicated the cycler had never been dropped nor physically damaged and confirmed that the spark only occurred once on the day the patient contact called into technical support.The pdrn stated that no burning smell melting or flame was noted.The pdrn stated that the patient missed several treatments in the absence of the cycler issue and did not immediately report the event or missed treatments.The pdrn confirmed the patient received a replacement cycler and has had had no further issues.The cycler has been 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: 13415964
• MDR Text Key: 284870230
• Report Number: 2937457-2022-00169
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

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
• Device Age: MO
• Initial Date Manufacturer Received: 01/28/2022
• Initial Date FDA Received: 02/01/2022
• Supplement Dates Manufacturer Received: 04/28/2022
• Supplement Dates FDA Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2019
• 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