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

Model Number LIBERTY SELECT CYCLER

Device Problem Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2018

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 a patient observed a spark while plugging the power cord into the cycler.The patient called technical services to report a blank screen.During troubleshooting the patient contact observed the power cord being loose at the cycler connection point.When the patient contact attempted to secure the power cord, a spark was observed.Upon follow up with the patient contact it was confirmed that the patient did not experience any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The pdrn stated that the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and stated the patient was able to complete the peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd).The patient has received a new cycler which is working well and continuing with pd therapy without issue.The cycler was reported to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

The reported symptom (spark) was not confirmed.The reported symptom (blank screen) was not confirmed.An external visual inspection showed no signs of physical damage.After powering on the cycler, the display was functioning and reached the home screen as intended without any issues.The cycler was left on for 5 hours, and the display screen did not go blank at any point.Voltage check passed.Pump integrity test passed.There were no discrepancies encountered during the internal inspection of the cycler.There were no indications of any sparks coming from the cycler during the above testing of the cycler.

• Brand Name: LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 7723085
• MDR Text Key: 115195949
• Report Number: 2937457-2018-02132
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K171652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LIBERTY SELECT CYCLER
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Device Age: MO
• Date Manufacturer Received: 07/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD SOLUTION; LIBERTY CYCLER SET