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

Catalog Number RTLR180343

Device Problems Thermal Decomposition of Device (1071); Sparking (2595)

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

Event Date 01/10/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A peritoneal dialysis (pd) patient reported that a fresenius liberty select cycler lost power.The patient rebooted the machine and upon power up, the screen went dark and a spark emitted from the back of the machine.The cause of the spark is unknown.Upon follow up, the patient¿s caregiver stated the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and confirmed that the patient was able to complete the peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd).The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient has received a new cycler which is working well and is continuing peritoneal dialysis therapy with no further issues.The cycler was returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed on the cycler and showed that the power entry module was pushed inward.An as-received simulated treatment was performed on the cycler and completed without failures.There were no instances of sparking or a blank display during testing.The cycler underwent and passed a system air leak test, valve actuation test, and voltage check.An internal visual inspection identified evidence of an insect infestation in the bottom cover access underneath the pump assembly.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.

• 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
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: matthew amaral ; 920 winter st.; waltham, MA 02451 ; 7816999758
• MDR Report Key: 8257483
• MDR Text Key: 133376742
• Report Number: 2937457-2019-00180
• 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,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2019

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 Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Device Age: MO
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 01/17/2019
• Supplement Dates Manufacturer Received: 02/05/2019; 02/08/2019
• Supplement Dates FDA Received: 02/05/2019; 02/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2012
• 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