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 02/15/2021

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer.A damaged power entry module was noted during an external visual inspection.There was no dried fluid nor particulates within the cassette area.There were no burrs or sharp edges in the cassette area that could have punctured the cassette membrane.A pre- accelerated stress test (ast) simulated treatment was initiated and completed without failures.The cycler underwent and passed a voltage check, hipot test, patient hipot test, and a 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 cycler found dried fluid within the recess of the bottom cover adjacent to the pump.The cause of the observed dried fluid could not be determined.There were no other visual discrepancies 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 peritoneal dialysis (pd) patient contacted fresenius technical support to report the liberty select cycler powered down several times tonight.Patient inspected the cycler and confirmed it was setup correctly yet the display remained blank.The fresenius technical support representative issued a replacement cycler and advised the patient to discontinue using the machine.The patient was advised to inform the peritoneal dialysis registered nurse (pdrn) of the cycler replacement, and change the flow alert option to no on the replacement cycler.There was no patient harm or adverse event, and no medical intervention was required.The patient will complete therapy using manual treatment.Upon follow up with the patient it was reported that sparks were observed where the cycler was plugged in.Further attempts were made to acquire additional information from the patient, however, a response was not 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: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 11546021
• MDR Text Key: 242747932
• Report Number: 2937457-2021-00472
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/22/2021

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: 02/24/2021
• Device Age: MO
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 03/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2020
• 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