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

Catalog Number RTLR180343

Device Problem Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2024

Event Type  malfunction  

Event Description

It was reported by a peritoneal dialysis (pd) patient's nurse that sparks were seen coming from the back of the cycler where the power cord plugs in.The patient continued to use the cycler and complete treatment.The patient was issued a new cycler.In a follow up, the patient's pd nurse verified the event and said there was no harm, intervention or adverse event due to the sparks.The patient received a new cycler which is working well with no further issues.The cycler is available to return as a sample product.

Manufacturer Narrative

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

• 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: 19006879
• MDR Text Key: 339296255
• Report Number: 0002937457-2024-00528
• 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: K222318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/28/2014
• 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
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 80 KG