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 07/02/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A nurse at a user facility reported that sparks were coming from the backside of the liberty select cycler during a patient¿s peritoneal dialysis (pd) treatment.A replacement cycler was issued in response to the reported issue.A user facility nurse stated during follow-up that the display would flicker on and off and sparks were coming from the backside of the cycler where the power cord connects to the machine.The nurse stated that the patient was able to complete treatment on the machine without experiencing a serious injury, adverse event, or requiring any medical intervention.The nurse stated that the replacement cycler has been received and the old cycler is scheduled to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Correction: g3.The received date was inadvertently submitted as 07/06/2021 in the initial mdr.The correct g3 date is 07/02/2021.

Event Description

A nurse at a user facility reported that sparks were coming from the backside of the liberty select cycler during a patient¿s peritoneal dialysis (pd) treatment.A replacement cycler was issued in response to the reported issue.A user facility nurse stated during follow-up that the display would flicker on and off and sparks were coming from the backside of the cycler where the power cord connects to the machine.The nurse stated that the patient was able to complete treatment on the machine without experiencing a serious injury, adverse event, or requiring any medical intervention.The nurse stated that the replacement cycler has been received and the old cycler is scheduled to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Additional information: d9, h3: plant investigation: the actual device was returned to the manufacturer.No physical damage was noted during an external visual inspection.A post- accelerated stress test (ast) simulated treatment with reduced dwells was performed and completed without failures.The cycler underwent and passed a hi pot test, a patient hi pot test, a current leakage test, and a voltage check.There was no sign of sparking or electrical issues encountered.All voltage readings were within specification.No visual discrepancies were observed during the internal inspection.A review of the device manufacturing records was conducted and 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, no malfunctions were found that could have caused or contributed to the reported event.The cycler performed as designed and an associated cause could not be determined.The cycler was refurbished following the evaluation.

Event Description

A nurse at a user facility reported that sparks were coming from the backside of the liberty select cycler during a patient¿s peritoneal dialysis (pd) treatment.A replacement cycler was issued in response to the reported issue.A user facility nurse stated during follow-up that the display would flicker on and off and sparks were coming from the backside of the cycler where the power cord connects to the machine.The nurse stated that the patient was able to complete treatment on the machine without experiencing a serious injury, adverse event, or requiring any medical intervention.The nurse stated that the replacement cycler has been received and the old cycler is scheduled 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
• MDR Report Key: 12122000
• MDR Text Key: 260121357
• Report Number: 2937457-2021-01403
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K181108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2021

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: 07/09/2021
• Device Age: MO
• Initial Date Manufacturer Received: 07/06/2021
• Initial Date FDA Received: 07/06/2021
• Supplement Dates Manufacturer Received: 07/14/2021; 07/22/2021
• Supplement Dates FDA Received: 07/21/2021; 08/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY CYCLER SET; DELFLEX PD FLUID; LIBERTY CYCLER SET