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 07/14/2023

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 the screen of a patient¿s liberty select cycler went blank during power up of the cycler during their peritoneal dialysis (pd) treatment.The patient saw a spark come from the outlet where the cycler was plugged in.There were no recent power outages in the home or in the area reported.There was not sound when the ok and stop keys pressed.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 not available.Upon follow up, it was confirmed that there were no adverse events or medical intervention required as a result of the reported event.The patient did complete treatment manually.The cycler was returned to the manufacturer and a replacement cycler was provided and received.

Manufacturer Narrative

Additional information provided in d9 and 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.The cycler underwent and passed a voltage check, hipot test, patient hipot test, and safety analyzer test.The simulated treatment pre-accelerated stress test (ast) 15 minute 1000 ml test failed.Failure due to cycler encountering a pressure leak alarm caused by a pressure leak from pneumatic valve 1.Replaced pneumatic valve 1 to continue testing.The simulated treatment pre-ast 15 minute 1000 ml test passed.There were no visual discrepancies encountered during the internal inspection.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 the screen of a patient¿s liberty select cycler went blank during power up of the cycler during their peritoneal dialysis (pd) treatment.The patient saw a spark come from the outlet where the cycler was plugged in.There were no recent power outages in the home or in the area reported.There was not sound when the ok and stop keys pressed.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 not available.Upon follow up, it was confirmed that there were no adverse events or medical intervention required as a result of the reported event.The patient did complete treatment manually.The cycler was returned to the manufacturer and a replacement cycler was provided and received.

• 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: 17369881
• MDR Text Key: 319481448
• Report Number: 0002937457-2023-01050
• Device Sequence Number: 1
• Product Code: FKX
• 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: 09/20/2023

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: 07/14/2023
• Initial Date FDA Received: 07/21/2023
• Supplement Dates Manufacturer Received: 09/15/2023
• Supplement Dates FDA Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2020
• 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
• Patient Sex: Female