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

Model Number 180343

Device Problem Melted (1385)

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

Event Date 02/18/2020

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 that a peritoneal dialysis (pd) patient observed that the antenna on the (b)(6) 2g liberty modem (serial # (b)(4)) got hot and melted at the connection point with the modem.It was indicated that the issue was caused by a power surge.The modem¿s connections and leds were inspected by the patient's contact and no other issues were identified.The patient¿s contact was advised to discontinue use of the modem.A replacement modem was issued and a return pick up was scheduled for the reported modem.Upon follow up, the patient's contact indicated they are unsure if the event occurred during treatment.The patient was able to complete treatment that day.There was no adverse events, symptoms, nor medical intervention required as a result of the event.There were no sparks, flames, nor smoke observed and there was no environmental damage.The modem replacement was scheduled to arrive that day and the reported modem was scheduled to be picked up near the end of february 2020 and returned for physical evaluation by the manufacturer.

Manufacturer Narrative

Plant investigation:the device was not returned to the manufacturer for physical evaluation.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 9740785
• MDR Text Key: 193427738
• Report Number: 2937457-2020-00363
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• 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?: No
• Device Age: MO
• Date Manufacturer Received: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Age: 68 YR
• Patient Weight: 76